Trial Outcomes & Findings for The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System (NCT NCT04559945)
NCT ID: NCT04559945
Last Updated: 2026-05-20
Results Overview
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. Percentage of participants free from complications are reported
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1276 participants
Primary outcome timeframe
6 weeks
Results posted on
2026-05-20
Participant Flow
Participant milestones
| Measure |
Aveir VR Leadless Pacemaker
Subjects who signed an approved informed consent form and had an attempted Aveir VR implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Overall Study
STARTED
|
324
|
|
Overall Study
Successful Implants
|
319
|
|
Overall Study
2-Week Visit
|
313
|
|
Overall Study
6-Week Visit
|
304
|
|
Overall Study
3-Month Visit
|
302
|
|
Overall Study
6-Month Visit
|
274
|
|
Overall Study
COMPLETED
|
178
|
|
Overall Study
NOT COMPLETED
|
146
|
Reasons for withdrawal
| Measure |
Aveir VR Leadless Pacemaker
Subjects who signed an approved informed consent form and had an attempted Aveir VR implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Overall Study
Awaiting 12-Month Visit
|
99
|
|
Overall Study
Death
|
29
|
|
Overall Study
Missed 12-Month Visit
|
6
|
|
Overall Study
withdrawn
|
12
|
Baseline Characteristics
The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
Baseline characteristics by cohort
| Measure |
Aveir VR Leadless Pacemaker
n=324 Participants
Subjects who signed an approved informed consent form and had an attempted Aveir VR implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Age, Continuous
|
75.6 Years
STANDARD_DEVIATION 11.3 • n=30 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
201 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
230 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
82 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
233 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Declined or Unable to Disclose Due to Local Regulation
|
73 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
4 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
169 Participants
n=30 Participants
|
|
Region of Enrollment
Canada
|
82 Participants
n=30 Participants
|
|
Region of Enrollment
Spain
|
27 Participants
n=30 Participants
|
|
Region of Enrollment
Czechia
|
24 Participants
n=30 Participants
|
|
Region of Enrollment
France
|
11 Participants
n=30 Participants
|
|
Region of Enrollment
Netherlands
|
5 Participants
n=30 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=30 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=30 Participants
|
|
Pacemaker Indication
Chronic AF with 2nd or 3rd Degree AV Block or Bundle Branch Block, including slow ventricular rates
|
165 Participants
n=30 Participants
|
|
Pacemaker Indication
Sinus Rhythm with 2nd or 3rd Degree AV Block or Bundle Branch Block
|
65 Participants
n=30 Participants
|
|
Pacemaker Indication
Sinus Bradycardia with Infrequent Pauses or Unexplained Syncope
|
94 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: First 200 Aveir VR subjects. Subjects who withdrew or died prior to the 6-week post-implant visit without a complication were excluded.
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. Percentage of participants free from complications are reported
Outcome measures
| Measure |
Aveir VR Leadless Pacemaker
n=198 Participants
Subjects who signed an approved informed consent form and had an attempted Aveir VR implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Complication-Free Rate (CFR)
|
96.0 percentage of participants
Interval 92.2 to 98.2
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: First 210 Aveir VR subjects within the enrolled population. Subjects who withdrew or died prior to the 12-Month post-implant visit without a complication were censored.
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. The complication free rate reported describes the Kaplan-Meier estimate of the percentage of patients that had no complications at the given time point.
Outcome measures
| Measure |
Aveir VR Leadless Pacemaker
n=210 Participants
Subjects who signed an approved informed consent form and had an attempted Aveir VR implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Complication-Free Rate (CFR)
|
93.2 percentage of participants
Interval 88.7 to 95.9
|
PRIMARY outcome
Timeframe: 6 Weeks (Aveir VR Leadless Pacemaker arm)Population: First 200 subjects within the enrolled Aveir VR population with a successful implant
Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes, which are defined as pacing threshold \<=2.0V at 0.4 ms pulse width and R-wave amplitude =\>5.0 mV or =\> value at implant.
Outcome measures
| Measure |
Aveir VR Leadless Pacemaker
n=196 Participants
Subjects who signed an approved informed consent form and had an attempted Aveir VR implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
|
95.9 percentage of participants
Interval 92.1 to 98.2
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: First 210 subjects within the enrolled Aveir VR population with a successful implant
Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes at 12-Month post-implant visit, which are defined as pacing threshold \<=2.0V at 0.4 ms pulse width and R-wave amplitude =\>5.0 mV or =\> value at implant.
Outcome measures
| Measure |
Aveir VR Leadless Pacemaker
n=205 Participants
Subjects who signed an approved informed consent form and had an attempted Aveir VR implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
|
95.1 percentage of participants
Interval 91.2 to 97.6
|
SECONDARY outcome
Timeframe: 3 month follow upPopulation: Subjects within the enrolled Aveir VR population with a successful implant who completed the six-minute walk test and completed at least stage 3 of the CAEP.
Temperature-based rate response feature was evaluated to determine whether an appropriate and proportional rate response was achieved during maximal effort graded treadmill exercise testing protocol (CAEP). Subjects were asked to perform a six-minute walk test to identify optimal sensor parameters prior to conducting a CAEP test. Exercise test data provide an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit. Since both axes are normalized, there is no unit of measure. The vertical axis is derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload.
Outcome measures
| Measure |
Aveir VR Leadless Pacemaker
n=17 Participants
Subjects who signed an approved informed consent form and had an attempted Aveir VR implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Appropriate and Proportional Rate Response During Graded Exercise Testing
|
0.93 unitless
Interval 0.78 to 1.08
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All subjects within the implanted Nanostim population from The LEADLESS II IDE Study (Phase I) - NCT02030418
All-Cause Mortality through 2 years among subjects implanted with the Nanostim Leadless Pacemaker. The Nanostim Leadless Pacemaker is functionally similar to the Aveir VR Leadless Pacemaker, and was evaluated in The LEADLESS II IDE Study (Phase I) - NCT02030418. For detailed demographic and study information including adverse events, refer to NCT02030418
Outcome measures
| Measure |
Aveir VR Leadless Pacemaker
n=917 Participants
Subjects who signed an approved informed consent form and had an attempted Aveir VR implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Survival Rate of Patients Implanted With the Nanostim Leadless Pacemaker
|
85.3 percent probability
Interval 82.7 to 87.4
|
Adverse Events
Aveir VR Leadless Pacemaker
Serious events: 98 serious events
Other events: 60 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Aveir VR Leadless Pacemaker
n=324 participants at risk
Subjects who signed an approved informed consent form and had an attempted Aveir VR implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.93%
3/324 • Number of events 4 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Angina Pectoris
|
0.93%
3/324 • Number of events 3 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Cardiac Arrhythmias
|
2.5%
8/324 • Number of events 12 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Cardiac Perforation
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Dyspnea
|
0.62%
2/324 • Number of events 2 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Heart Failure
|
4.6%
15/324 • Number of events 23 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Myocardial Infarction
|
1.5%
5/324 • Number of events 5 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Aortic Stenosis
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Atrioventricular Conduction Disease
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Cardiac Arrest
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Carotid Artery Stenosis
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Hypotension
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Ischemic Heart Disease
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Pulmonary Hypertension
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Reduced Ejection Fraction
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
RV Pacing Induced Cardiomyopathy
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Palpitations
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Valve Damage
|
0.31%
1/324 • Number of events 3 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Endocrine disorders
Diabetes
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Cardia Incompetence
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Dysphagia
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Gastritis
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
GI Bleeding
|
1.2%
4/324 • Number of events 4 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Vomiting
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.62%
2/324 • Number of events 3 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Hepatobiliary disorders
Choledocholithiasis
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Immune system disorders
Rejection of Transplanted Organ
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Endocarditis
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Infection, Local at Access Site, or Systemic
|
4.3%
14/324 • Number of events 15 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Fever (Unknown Origin)
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Sepsis
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Access Site Bleeding
|
1.2%
4/324 • Number of events 4 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Cardiac Tamponade
|
1.5%
5/324 • Number of events 5 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Embolism
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Excessive Bleeding
|
0.93%
3/324 • Number of events 3 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Fall
|
0.62%
2/324 • Number of events 2 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Hypotension
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm Formation
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Thrombosis
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Investigations
Electrolyte Disbalance
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Metabolism and nutrition disorders
Amyloidosis
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Musculoskeletal and connective tissue disorders
Femoral Fracture
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Musculoskeletal and connective tissue disorders
Herniated Cervical Disk
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.62%
2/324 • Number of events 2 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Musculoskeletal and connective tissue disorders
Pelvic Fracture
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Musculoskeletal and connective tissue disorders
Vertebral Fracture
|
0.93%
3/324 • Number of events 3 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Disease
|
1.9%
6/324 • Number of events 6 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Mass
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Anoxic Brain Injury
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Dementia
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Depression
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Stroke
|
0.62%
2/324 • Number of events 2 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.93%
3/324 • Number of events 3 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Device Dislodgement
|
0.62%
2/324 • Number of events 2 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Premature Deployment with/without Device Migration
|
0.93%
3/324 • Number of events 3 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
RV Pacing Induced Cardiomyopathy
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Pacemaker Syndrome
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Renal and urinary disorders
Urinary Retention
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Renal and urinary disorders
Renal Failure
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.62%
2/324 • Number of events 2 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Social circumstances
Fall
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Surgical and medical procedures
Hip Fracture
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Aortic Aneurysm
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Pseudoaneurysm Formation
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Thromboemboli
|
0.62%
2/324 • Number of events 2 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Thrombosis
|
0.93%
3/324 • Number of events 3 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Dizziness
|
0.93%
3/324 • Number of events 3 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Dyspnea
|
0.62%
2/324 • Number of events 2 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Aspiration
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Change in Mental Status
|
0.93%
3/324 • Number of events 3 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Chest Pain
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Constitutional Syndrome
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Cough
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Death, Unknown Cause
|
0.93%
3/324 • Number of events 3 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Failure to Thrive
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Frailty
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Hyperkalemia
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Malnutrition
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Neurocardiogenic Disorder
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Edema
|
0.31%
1/324 • Number of events 1 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Syncope
|
0.93%
3/324 • Number of events 8 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
allergic reaction to vancomycin
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
aortic dissection
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
asystole during implant procedure
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
bacteremia
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Bell's Palsy
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
cardiomyopathy
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Cardiopulmonary Arrest
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Skin and subcutaneous tissue disorders
Cellullitis
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Cerebrovascular Accident
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Change in Mental Status Post Procedure
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Contrast Induced Nephropathy
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Detached Docking Button
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Vascular disorders
Damage to Vessels
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Decreased Level of Consciousness
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Dehydration
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Device Pocket Infection (Biv ICD)
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Elective Device Replacement
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Elective Replacement Indicator
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Renal and urinary disorders
End Stage Renal Disease
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Endocarditis of Prosthetic Valves
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Epistaxis
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Product Issues
Failure to Capture/Loss of Capture
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Fatiuge
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Femoral-Popliteal Bypass Graft Occlusion
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Hand Swelling
|
0.00%
0/324 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
Other adverse events
| Measure |
Aveir VR Leadless Pacemaker
n=324 participants at risk
Subjects who signed an approved informed consent form and had an attempted Aveir VR implant, with no pre-existing implanted pacemaker at the time of consent
|
|---|---|
|
Injury, poisoning and procedural complications
Access Site Bleeding Event
|
3.4%
11/324 • Number of events 11 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Injury, poisoning and procedural complications
Hematoma Formation, Including Retroperitoneal Hemorrhage
|
3.1%
10/324 • Number of events 10 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Dyspnea
|
1.5%
5/324 • Number of events 5 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Dyspnea
|
3.1%
10/324 • Number of events 10 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Cardiac disorders
Cardiac Arrhythmias
|
6.2%
20/324 • Number of events 22 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Syncope
|
2.2%
7/324 • Number of events 9 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
Infections and infestations
Infection, Local at Access Site, or Systemic
|
2.5%
8/324 • Number of events 11 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
|
General disorders
Dizziness
|
1.9%
6/324 • Number of events 6 • Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months)
Regular investigator assessment of adverse events reported on a case report form. Seriousness and device-or-procedure relatedness for all reported events were based on the adjudications from an independent clinical events committee.
|
Additional Information
Nicole Harbert, Director of Clinical Research
Abbott Medical Devices, Cardiac Rhythm Management Division
Phone: 972-526-4841
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators are permitted to publish study-related results according to the local study contract and protocol. Draft publications or presentations must be provided to the Sponsor prior to any submission to determine if any confidential information is disclosed. Upon Sponsor request, the public disclosure may be delayed to enable the Sponsor to secure proprietary protection. The Sponsor shall not exercise editorial control over the proposed publication other than to correct technical accuracy.
- Publication restrictions are in place
Restriction type: OTHER