PULSED AF Post-Approval Study

Recruiting

• Conditions: Atrial Fibrillation

• 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.

Study Timeline

• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-29
• Study Start: 2024-11-04
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-01
• Last Update Posted: 2025-10-07
• Primary Completion: 2026-06-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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.

Trial Locations

Locations (11)

Pikeville Medical Center; 🇺🇸 Whitesburg, Kentucky, United States

Southcoast Health System; 🇺🇸 Fall River, Massachusetts, United States

Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

The Valley Hospital; 🇺🇸 New York, New York, United States

Northwell Health Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Mount Carmel Grove City Medical Center; 🇺🇸 Grove City, Ohio, United States

Doylestown Health Cardiology a division of Doylestown Health Physicians; 🇺🇸 Doylestown, Pennsylvania, United States

AnMed Health Center; 🇺🇸 Anderson, South Carolina, United States

Medical University of South Carolina (MUSC); 🇺🇸 Charleston, South Carolina, United States

Texas Health Research & Education Institute; 🇺🇸 Dallas, Texas, United States

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