PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,950
- Locations
- 68
- Primary Endpoint
- Efficacy-Freedom from Atrial Fibrillation
Study Overview
Brief Summary
The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.
Detailed Description
The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to collect clinical performance and safety data in a broad patient population treated with the PulseSelect™ PFA system. The PulseSelect™ PFA System used in the study is market approved. The ablation procedure will be performed according to routine hospital practice. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is ≥ 18 years of age or minimum age as required by local regulations.
- •Subject has been diagnosed with atrial fibrillation (AF)
- •Planned procedure using commercially available PulseSelect™ PFA System.
- •Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements.
Exclusion Criteria
- •Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
- •Subject with exclusion criteria required by local law.
Outcomes
Primary Outcomes
Efficacy-Freedom from Atrial Fibrillation
Time Frame: ≥ 91 days after the index ablation procedure
Estimate the freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
Safety- Freedom from Device/Procedure Related Adverse Events
Time Frame: Within 6 months post-ablation
Estimate serious device and serious procedure-related adverse events for the PulseSelect™ PFA system
Secondary Outcomes
No secondary outcomes reported