Status:
RECRUITING
PULSED AF Post-Approval Study
Lead Sponsor:
Medtronic Cardiac Ablation Solutions
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief 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 occ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
- Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)
- Patient is ≥ 18 years of age
- Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System
- Willing and able 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
- Long-standing persistent AF (continuous AF sustained \>12 months)
- Prior left atrial catheter or surgical ablation
- Patient with life expectancy \< 36 months
- Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager
Exclusion
Key Trial Info
Start Date :
November 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT06578104
Start Date
November 4 2024
End Date
June 1 2029
Last Update
November 14 2025
Active Locations (14)
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1
Pikeville Medical Center
Whitesburg, Kentucky, United States, 41858-7428
2
Southcoast Health System
Fall River, Massachusetts, United States, 02720
3
Beaumont Health System
Royal Oak, Michigan, United States, 48073
4
Nebraska Medical Center
Omaha, Nebraska, United States, 68198