Trial Outcomes & Findings for Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead (NCT NCT03891329)
NCT ID: NCT03891329
Last Updated: 2024-09-27
Results Overview
Serious Adverse Device Effect (SADE)-free rate possibly or securely related to the Cor Family Internal Cardioverter Defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) until 3-month follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
3 months
Results posted on
2024-09-27
Participant Flow
130 patients completed the informed consent process and signed the informed consent sheet.
127 patients received one or more study devices implanted. 3 enrolled patients did not receive a study device. Two of those patients who did not receive a study were excluded from the analysis while the third patient underwent an implantation attempt and was therefore included in the general analysis population
Participant milestones
| Measure |
Acticor/Rivacor ICDs/CRT-Ds
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
|---|---|
|
Overall Study
STARTED
|
130
|
|
Overall Study
Patients With Implantation Attempt
|
128
|
|
Overall Study
Patients Implanted
|
127
|
|
Overall Study
COMPLETED
|
111
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Acticor/Rivacor ICDs/CRT-Ds
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Device explanted
|
3
|
|
Overall Study
No study device implanted
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Acticor/Rivacor ICDs/CRT-Ds
n=128 Participants
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 9.8 • n=128 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=128 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=128 Participants
|
|
Region of Enrollment
Austria
|
13 participants
n=128 Participants
|
|
Region of Enrollment
Latvia
|
17 participants
n=128 Participants
|
|
Region of Enrollment
Netherlands
|
21 participants
n=128 Participants
|
|
Region of Enrollment
Hungary
|
24 participants
n=128 Participants
|
|
Region of Enrollment
Slovakia
|
4 participants
n=128 Participants
|
|
Region of Enrollment
Switzerland
|
22 participants
n=128 Participants
|
|
Region of Enrollment
Germany
|
27 participants
n=128 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All patients who either had a primary endpoint or who had reached 3 months of follow-up
Serious Adverse Device Effect (SADE)-free rate possibly or securely related to the Cor Family Internal Cardioverter Defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) until 3-month follow-up
Outcome measures
| Measure |
Acticor/Rivacor ICDs/CRT-Ds
n=123 Participants
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
Kaplan-Meier-Estimate for the Cor-Family Related SADE-free Rate 365 Days After Implantation
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting.
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
|---|---|---|
|
Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up
|
122 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months, 12 monthsPopulation: Of 130 enrolled patients, 127 implanted with a COR Family ICD. Out of these, 123 patients were eligible for these endpoint analysis; 4 patients had premature study termination before day 61 after implantation without experiencing a Serious Adverse Device Effect related to the Cor Family device (SADE-d) and were excluded from analysis. For the 12-month endpoint, 111 patients who completed the study were eligible for endpoint analysis.
Application of the Kaplan-Meier method to estimate the 3-month (92 days) SADE-free rate and the 12-month (365 days) SADE-free rate
Outcome measures
| Measure |
Acticor/Rivacor ICDs/CRT-Ds
n=123 Participants
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
Kaplan-Meier-Estimate for the Cor-Family Related SADE-free Rate 365 Days After Implantation
n=111 Participants
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting.
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
|---|---|---|
|
Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate
|
99.2 percentage of participants
Interval 94.5 to 99.9
|
99.2 percentage of participants
Interval 94.5 to 99.9
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: In total, 52 assessments were received from the investigators: 24 assessments at time of implantation, 21 assessments at time of pre-hospital discharge, 7 assessments during 3-month follow-up visit
Investigators were asked to assess the overall handling of the Automatic LV VectorOpt test in patients who received a CRT-device. Assessments were collected during implantation, pre-hospital discharge, and 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate - poor -very poor.
Outcome measures
| Measure |
Acticor/Rivacor ICDs/CRT-Ds
n=52 handling-assessments
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
Kaplan-Meier-Estimate for the Cor-Family Related SADE-free Rate 365 Days After Implantation
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting.
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
|---|---|---|
|
Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator
Very good
|
21 Handling-assessment by investigator
|
—
|
|
Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator
Good
|
27 Handling-assessment by investigator
|
—
|
|
Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator
Adequate
|
3 Handling-assessment by investigator
|
—
|
|
Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator
Poor
|
1 Handling-assessment by investigator
|
—
|
|
Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator
Very poor
|
0 Handling-assessment by investigator
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: In total, 20 assessments were received from the investigator at the time of the 3-month follow-up visit.
Investigator were asked to assess the overall handling of the CRT AutoAdapt feature in patients who received a CRT-device. Assessments were collected during the 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate -poor -very poor.
Outcome measures
| Measure |
Acticor/Rivacor ICDs/CRT-Ds
n=20 handling-assessments
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
Kaplan-Meier-Estimate for the Cor-Family Related SADE-free Rate 365 Days After Implantation
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting.
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
|---|---|---|
|
Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator
Very good
|
7 Handling-assessment by investigator
|
—
|
|
Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator
Good
|
10 Handling-assessment by investigator
|
—
|
|
Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator
Adequate
|
3 Handling-assessment by investigator
|
—
|
|
Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator
Poor
|
0 Handling-assessment by investigator
|
—
|
|
Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator
Very poor
|
0 Handling-assessment by investigator
|
—
|
Adverse Events
Acticor/Rivacor ICDs/CRT-Ds
Serious events: 54 serious events
Other events: 42 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Acticor/Rivacor ICDs/CRT-Ds
n=130 participants at risk
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
Adverse drug reaction
|
3.1%
4/130 • Number of events 4 • Patients were followed for 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Vascular disorders
Aortic intramural haematoma
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Aortic valve incompetence
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Gastrointestinal disorders
Ascites
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
3/130 • Number of events 3 • Patients were followed for 1 year
|
|
Cardiac disorders
Atrioventricular block complete
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Investigations
Blood potassium decreased
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Bradycardia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Cardiac failure
|
6.9%
9/130 • Number of events 13 • Patients were followed for 1 year
|
|
Cardiac disorders
Cardiac failure chronic
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Cardiogenic shock
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Nervous system disorders
Cerebral ischaemia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
Chest pain
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Vascular disorders
Circulatory collapse
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Nervous system disorders
Cognitive disorder
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Coronary artery occlusion
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
Crepitations
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
Death
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Psychiatric disorders
Delirium
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Device connection issue
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Device electrical impedance issue
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Device lead damage
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Device pacing issue
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Investigations
Ejection fraction decreased
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Nervous system disorders
Epilepsy
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Gastrointestinal disorders
Gastric dysplasia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Infections and infestations
Gastroenteritis
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
General physical health deterioration
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Vascular disorders
Haematoma
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Vascular disorders
Haemodynamic instability
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Vascular disorders
Hypertensive crisis
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Vascular disorders
Hypotension
|
0.77%
1/130 • Number of events 3 • Patients were followed for 1 year
|
|
Endocrine disorders
Hypothyroidism
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
Implant site haematoma
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
General disorders
Implant site haemorrhage
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Injury, poisoning and procedural complications
Implantation complication
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
Inflammation
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Lead dislodgement
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haematoma
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Mitral valve incompetence
|
2.3%
3/130 • Number of events 3 • Patients were followed for 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
3/130 • Number of events 4 • Patients were followed for 1 year
|
|
Injury, poisoning and procedural complications
Postoperative hypotension
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Pulseless electrical activity
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Renal and urinary disorders
Renal disorder
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Renal and urinary disorders
Renal failure
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Sensing amplitude decreased
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Nervous system disorders
Syncope
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Cardiac disorders
Tachycardia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Ventricular dyssynchrony
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Ventricular fibrillation
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
3.1%
4/130 • Number of events 7 • Patients were followed for 1 year
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
Other adverse events
| Measure |
Acticor/Rivacor ICDs/CRT-Ds
n=130 participants at risk
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule
Plexa S DX: Implantation, measurements and follow-up schedule
|
|---|---|
|
General disorders
Adverse drug reaction
|
3.1%
4/130 • Number of events 5 • Patients were followed for 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Cardiac disorders
Atrial tachycardia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Investigations
Blood creatinine increased
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Injury, poisoning and procedural complications
Cardiac vein dissection
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
Chest pain
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Vascular disorders
Circulatory collapse
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Nervous system disorders
Cognitive disorder
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
Complication of device insertion
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
Condition aggravated
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Infections and infestations
Corona virus infection
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Nervous system disorders
Dementia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Device computer issue
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Device inappropriate shock delivery
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Device stimulation issue
|
2.3%
3/130 • Number of events 3 • Patients were followed for 1 year
|
|
Nervous system disorders
Dizziness
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Electromagnetic interference
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Vascular disorders
Hypertension
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Vascular disorders
Hypotension
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Endocrine disorders
Hypothyroidism
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
Implant site haematoma
|
3.1%
4/130 • Number of events 4 • Patients were followed for 1 year
|
|
General disorders
Implant site inflammation
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
General disorders
Implant site pain
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
General disorders
Implant site swelling
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Oversensing
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Infections and infestations
Pneumonia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Nervous system disorders
Radiculopathy
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Renal and urinary disorders
Renal impairment
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Nervous system disorders
Spinal cord compression
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Tachyarrhythmia
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Product Issues
Undersensing
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
1.5%
2/130 • Number of events 2 • Patients were followed for 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
|
Injury, poisoning and procedural complications
Wound
|
0.77%
1/130 • Number of events 1 • Patients were followed for 1 year
|
Additional Information
Director Clinical Project Management
BIOTRONIK SE & Co.KG
Phone: +49 30 68905
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place