PULSED AF Post-Approval Study
- Conditions
- Atrial Fibrillation
- Interventions
- Device: PulseSelect™ PFA system
- Registration Number
- NCT06578104
- Lead Sponsor
- Medtronic Cardiac Ablation Solutions
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 580
- A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
- Failure or intolerance of at least one Class I or III antiarrhythmic drug
- 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
- Long-standing persistent AF (continuous AF sustained >12 months)
- Prior left atrial ablation or left atrial surgical procedure
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Persistent PulseSelect™ PFA system Ablation using the PulseSelect™ PFA system Paroxysmal PulseSelect™ PFA system Ablation using the PulseSelect™ PFA system
- Primary Outcome Measures
Name Time Method Safety- Freedom from Device/Procedure Related Adverse Events 6 months post-ablation] Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system.
Efficacy-Freedom from Atrial Fibrillation 36-months after the index ablation procedure Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Southcoast Health System
🇺🇸Fall River, Massachusetts, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
The Valley Hospital
🇺🇸New York, New York, United States
Mount Carmel Grove City Medical Center
🇺🇸Grove City, Ohio, United States
AnMed Health Center
🇺🇸Anderson, South Carolina, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Northwell Health Lenox Hill Hospital
🇺🇸New York, New York, United States
Doylestown Health Cardiology a division of Doylestown Health Physicians
🇺🇸Doylestown, Pennsylvania, United States