Trial Outcomes & Findings for TactiFlex Paroxysmal Atrial Fibrillation IDE Trial (NCT NCT04356040)
NCT ID: NCT04356040
Last Updated: 2023-10-31
Results Overview
Tthe rate of device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80 days of initial procedure) that are defined below: * Atrio-esophageal fistula1 * Cardiac tamponade/perforation1 * Death * Heart block * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in diaphragmatic paralysis * Pulmonary edema * Pulmonary vein stenosis1 * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Vascular access complications (including major bleeding events) 1. Atrio-esophageal fistula, cardiac tamponade/perforation and pulmonary vein stenosis will be evaluated through 12-months.
COMPLETED
NA
355 participants
Through 12 months
2023-10-31
Participant Flow
Participant milestones
| Measure |
Paroxysmal AF - Main Study
TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
|
Paroxysmal AF HSP Sub-Study
TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
|
|---|---|---|
|
Overall Study
STARTED
|
305
|
50
|
|
Overall Study
Device Inserted and RF Energy Delivered
|
284
|
50
|
|
Overall Study
7-Day Visit
|
280
|
50
|
|
Overall Study
5-Week Visit
|
279
|
50
|
|
Overall Study
3-Month Visit
|
272
|
50
|
|
Overall Study
6-Month Visit
|
267
|
49
|
|
Overall Study
12-Month Visit
|
264
|
48
|
|
Overall Study
COMPLETED
|
268
|
48
|
|
Overall Study
NOT COMPLETED
|
37
|
2
|
Reasons for withdrawal
| Measure |
Paroxysmal AF - Main Study
TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
|
Paroxysmal AF HSP Sub-Study
TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
1
|
|
Overall Study
Enrollment Pause
|
10
|
0
|
|
Overall Study
Did not meet Inclusion/Exclusion criteria
|
7
|
0
|
|
Overall Study
Procedure aborted prior to device insertion into the vasculature
|
1
|
0
|
|
Overall Study
PI left institution
|
3
|
0
|
Baseline Characteristics
TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
Baseline characteristics by cohort
| Measure |
Paroxysmal AF - Main Study
n=284 Participants
TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
|
Paroxysmal AF HSP Sub-Study
n=50 Participants
TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
|
Total
n=334 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.0 years
n=99 Participants
|
67.0 years
n=107 Participants
|
65.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
180 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
264 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
309 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
262 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
306 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
29 participants
n=99 Participants
|
0 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Region of Enrollment
Hong Kong
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
185 participants
n=99 Participants
|
50 participants
n=107 Participants
|
235 participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
7 participants
n=99 Participants
|
0 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
31 participants
n=99 Participants
|
0 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=99 Participants
|
0 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Body Mass Index
|
28.4 kg/m^2
n=99 Participants
|
28.35 kg/m^2
n=107 Participants
|
28.4 kg/m^2
n=206 Participants
|
|
CHA2DS2Vasc Score
|
2 units on a scale
n=99 Participants
|
2 units on a scale
n=107 Participants
|
2 units on a scale
n=206 Participants
|
|
New York Heart Association Functional Classification
No Heart Failure
|
203 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
247 Participants
n=206 Participants
|
|
New York Heart Association Functional Classification
Class I
|
54 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
New York Heart Association Functional Classification
Class II
|
27 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
New York Heart Association Functional Classification
Class III or IV
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Left Ventricular Ejection Fraction
|
60.0 Percentage
n=99 Participants
|
55.0 Percentage
n=107 Participants
|
60.0 Percentage
n=206 Participants
|
|
Left Atrial Diameter
|
40.0 Millimeters
n=99 Participants
|
40.0 Millimeters
n=107 Participants
|
40.0 Millimeters
n=206 Participants
|
PRIMARY outcome
Timeframe: Through 12 monthsPopulation: The primary safety analysis population for the primary safety endpoint included all treated subjects who have completed their 7-day follow-up visit; or crossed the end of the 7-day visit window without the visit but with a primary safety endpoint event.
Tthe rate of device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80 days of initial procedure) that are defined below: * Atrio-esophageal fistula1 * Cardiac tamponade/perforation1 * Death * Heart block * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in diaphragmatic paralysis * Pulmonary edema * Pulmonary vein stenosis1 * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Vascular access complications (including major bleeding events) 1. Atrio-esophageal fistula, cardiac tamponade/perforation and pulmonary vein stenosis will be evaluated through 12-months.
Outcome measures
| Measure |
Main Study
n=280 Participants
TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
|
High Standard Power Sub-Study
n=50 Participants
TactiFlex SE - High Standard Power: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
|
|---|---|---|
|
Number of Participants With Device or Procedure-related Serious Adverse Events
|
12 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Through 12 monthsPopulation: All treated subjects
Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of \>30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period will not be considered a treatment failure. One repeat procedure will be allowed during the blanking period. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed drugs are taken at doses that do not exceed the previously failed dose.
Outcome measures
| Measure |
Main Study
n=284 Participants
TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
|
High Standard Power Sub-Study
n=50 Participants
TactiFlex SE - High Standard Power: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
|
|---|---|---|
|
KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence
|
72.9 percentage
Interval 67.2 to 78.6
|
71.8 percentage
Interval 57.0 to 86.6
|
SECONDARY outcome
Timeframe: Through 12 monthsPopulation: All Treated Subjects
Freedom from documented symptomatic atrial fibrillation/atrial flutter/atrial tachycardia episodes of \>30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmias drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmias drugs are taken at doses that do not exceed the previously failed dose.
Outcome measures
| Measure |
Main Study
n=284 Participants
TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
|
High Standard Power Sub-Study
n=50 Participants
TactiFlex SE - High Standard Power: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
|
|---|---|---|
|
KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence
|
80.4 percentage
Interval 75.2 to 85.6
|
75.9 percentage
Interval 61.5 to 90.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All treated subjects
Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of \>30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. Any repeat ablation procedure in the left atrium will be considered a treatment failure. Failure to achieve acute procedural success during the ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmic drugs are taken at doses that do not exceed the previously failed dose.
Outcome measures
| Measure |
Main Study
n=284 Participants
TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
|
High Standard Power Sub-Study
n=50 Participants
TactiFlex SE - High Standard Power: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
|
|---|---|---|
|
KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure
|
71.5 percentage
Interval 65.7 to 77.3
|
71.8 percentage
Interval 57.0 to 86.6
|
SECONDARY outcome
Timeframe: Through 12 monthsPopulation: All treated subjects
Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of \>30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period). Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, any use of a Class I or III anti-arrhythmic drugs will count as an effectiveness failure.
Outcome measures
| Measure |
Main Study
n=284 Participants
TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
|
High Standard Power Sub-Study
n=50 Participants
TactiFlex SE - High Standard Power: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
|
|---|---|---|
|
KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs
|
64.0 percentage
Interval 58.0 to 70.0
|
65.8 percentage
Interval 50.9 to 80.7
|
Adverse Events
Paroxysmal AF - Main Study
Paroxysmal AF HSP Sub-Study
Serious adverse events
| Measure |
Paroxysmal AF - Main Study
n=284 participants at risk
TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
|
Paroxysmal AF HSP Sub-Study
n=50 participants at risk
TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
|
|---|---|---|
|
Infections and infestations
Infection
|
3.2%
9/284 • Number of events 10 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Cardiac disorders
Arrhythmia Pre-Existing
|
2.8%
8/284 • Number of events 8 • 12 months
|
0.00%
0/50 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer/Non-Malignant Tumor
|
1.4%
4/284 • Number of events 4 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Pericarditis
|
1.4%
4/284 • Number of events 4 • 12 months
|
0.00%
0/50 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
1.4%
4/284 • Number of events 4 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Cardiac disorders
Chest Pain/Angina (Cardiac)
|
1.1%
3/284 • Number of events 3 • 12 months
|
0.00%
0/50 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Disorder
|
1.1%
3/284 • Number of events 3 • 12 months
|
0.00%
0/50 • 12 months
|
|
Vascular disorders
Vascular Access Complications
|
1.1%
3/284 • Number of events 3 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Cardiac Tamponade
|
0.70%
2/284 • Number of events 2 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Coronary Artery Disease
|
0.70%
2/284 • Number of events 2 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Pain (Non-Cardiac)
|
0.70%
2/284 • Number of events 2 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Cardiac disorders
Pericardial Effusion
|
0.70%
2/284 • Number of events 2 • 12 months
|
0.00%
0/50 • 12 months
|
|
General disorders
Syncope/Dizziness
|
0.70%
2/284 • Number of events 2 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Thrombosis/Thrombus
|
0.35%
1/284 • Number of events 2 • 12 months
|
0.00%
0/50 • 12 months
|
|
Skin and subcutaneous tissue disorders
Vascular Bleeding/Local Hematomas Ecchymosis
|
0.70%
2/284 • Number of events 2 • 12 months
|
0.00%
0/50 • 12 months
|
|
General disorders
Abnormal Labs (e.g., Creatine phosphokinase, Creatinine, Troponin)
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Arrhythmia New
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Atrioventricular Block/Bundle Branch Block
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Blood and lymphatic system disorders
Bleeding/Anemia
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Cardiac Perforation/Injury
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Blood and lymphatic system disorders
Cerebrovascular Accident/Stroke
|
0.35%
1/284 • Number of events 1 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Endocrine disorders
Endocrine Disease/Disorder
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Heart Failure/Pump Failure
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Nervous system disorders
Nerve System Damage/Injury/Disease
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Renal and urinary disorders
Renal Decompensation/Kidney Injury
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Blood and lymphatic system disorders
Transient Ischemic Attack
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Valvular Damage or Insufficiency
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Injury, poisoning and procedural complications
Vascular Damage (e.g., Perforation, Dissection, Obstruction)
|
0.35%
1/284 • Number of events 1 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Vasovagal Reaction
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
General disorders
Volume Overload
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Eye disorders
Abnormal Vision
|
0.00%
0/284 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Elective Procedure/Surgery
|
0.00%
0/284 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Other: Diarrhea
|
0.00%
0/284 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Other: Urinary/Urine Retention
|
1.1%
3/284 • Number of events 3 • 12 months
|
0.00%
0/50 • 12 months
|
|
Gastrointestinal disorders
Other: Abdominal Pain
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Other: Aortic Stenosis
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Other: Atrial Fibrillation
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Other: Collapsed Lung
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
General disorders
Other: Motorcycle Crash
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Other: Pericardial-Esophageal Fistula
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Injury, poisoning and procedural complications
Other: Pseudoaneurysm of Common Femoral Artery
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Other: Pulmonary Sarcoidosis
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
General disorders
Other: Spontaneous Subarachnoid Hemorrhage
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Renal and urinary disorders
Other: Ureteral Calculus/Stone
|
0.70%
2/284 • Number of events 2 • 12 months
|
0.00%
0/50 • 12 months
|
|
Renal and urinary disorders
Other: Urinary Frequency Needing transurethral resection of the prostate
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
General disorders
Other: Urinary Retention with Acute Kidney Injury
|
0.35%
1/284 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
Other adverse events
| Measure |
Paroxysmal AF - Main Study
n=284 participants at risk
TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
|
Paroxysmal AF HSP Sub-Study
n=50 participants at risk
TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
|
|---|---|---|
|
Endocrine disorders
Volume Overload
|
1.8%
5/284 • Number of events 5 • 12 months
|
6.0%
3/50 • Number of events 3 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The data and results from the clinical investigation are the sole property of the Sponsor. The Investigators will not use this clinical investigation-related data without the written consent of the Sponsor for any purpose other than for clinical investigation completion or for generation of publication materials, as referenced in the Clinical Trial Agreement. Single-center results are not allowed to be published or presented before the multi-center results.
- Publication restrictions are in place
Restriction type: OTHER