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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P230017 / PAS001 |
| Date Original Protocol Accepted |
06/18/2024
|
| Date Current Protocol Accepted |
|
| Study Name |
PULSED AF Post Approval Study
|
| Device Name |
PulseSelect™ Pulsed Field Ablation (PFA) system
|
| Clinical Trial Number(s) |
NCT04198701
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, multi-center, global, registry-based, observational study
|
| Study Population |
Subjects greater than or equal to 18 years of age (or minimum age as required by local regulations) who have a recommendation for an ablation with the PulseSelect™ PFA System may be approached regarding enrollment in this study.
|
| Sample Size |
Number of subjects: 580
Assumptions for sample size estimation: ~10% attrition
Number of sites: 15
Sites location: US and OUS
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| Key Study Endpoints |
Safety Endpoints
Primary: Estimate the rate of major procedural complications for catheter ablation using the PulseSelect™ PFA System.
Effectiveness Endpoints
Primary: Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA System.
Ancillary Objectives:
1. Characterize the PulseSelect™ PFA System ablation procedure, including but not limited to:
o Acute procedural success
o Total procedure time
o Left Atrial (LA) dwell time
o Total Fluoroscopy time
o Total PulseSelect™ PFA System ablation time
o Number and location of applications
2. Estimate change in quality of life (QoL) through 36 months.
3. Estimate the freedom from symptomatic AF/AFL/AT recurrence through 36 months.
4. Characterize all reported AEs through 36 months.
5. Estimate the rate of procedure-related mortality of the AF ablation procedure using the PulseSelect™ PFA system.
6. Estimate the rate of early mortality after ablation using the PulseSelect™ PFA system through 3 months post-procedure.
7. Estimate the rate of cardiac arrest that occurs during or after the AF ablation procedure (index or repeat) using the PulseSelect™ PFA system
through 12 months post-procedure.
8. Estimate the rate of new left ventricular wall motion abnormality seen on echocardiogram at 12 months post-ablation.
9. Estimate the rate of all serious device or serious procedure related adverse events for catheter ablation using the PulseSelect™ PFA System
through 12 months post-procedure.
10. Estimate the freedom from AF/AFL/AT recurrence post-90-day blanking period through 12 months post-ablation using the PulseSelect™
PFA System.
11. Estimate the freedom from AF/AFL/AT recurrence post-90-day blanking period through 12, 24, and 36 months post-ablation using the
PulseSelect™ PFA System for subjects off all Class I/III AADs.
|
| Follow-up Visits and Length of Follow-up |
3-, 6-, 12-, 24-, 36-months
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