Trials / Recruiting
RecruitingNCT06578104
PULSED AF Post-Approval Study
PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 580 (estimated)
- Sponsor
- Medtronic Cardiac Ablation Solutions · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.
Detailed description
PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PulseSelect™ PFA system | Ablation using the PulseSelect™ PFA system |
Timeline
- Start date
- 2024-11-04
- Primary completion
- 2026-06-01
- Completion
- 2029-06-01
- First posted
- 2024-08-29
- Last updated
- 2026-03-27
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06578104. Inclusion in this directory is not an endorsement.