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NCT06578104Recruiting

PULSED AF Post-Approval Study

Medtronic Cardiac Ablation Solutions

Start Date

11/4/2024

Completion Date

4/30/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

PulseSelect™ PFA system

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Conditions

Atrial Fibrillation

Locations

University of South Florida Health (USF)

Tampa, Florida 33606-3603

United States

Piedmont Heart Institute

Atlanta, Georgia 30309

United States

Endeavor Health Swedish Hospital

Chicago, Illinois 60625

United States

Pikeville Medical Center

Whitesburg, Kentucky 41858-7428

United States

Southcoast Health System

Fall River, Massachusetts 02720

United States

Beaumont Health System

Royal Oak, Michigan 48073

United States

Nebraska Medical Center

Omaha, Nebraska 68198

United States

The Valley Hospital

New York, New York 10025

United States

Northwell Health Lenox Hill Hospital

New York, New York 10075

United States

Duke University Medical Center (DUMC)

Durham, North Carolina 27710

United States

Bethesda North Hospital

Cincinnati, Ohio 45220

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 045218

United States

Mount Carmel Grove City Medical Center

Grove City, Ohio 43123

United States

Doylestown Health Cardiology a division of Doylestown Health Physicians

Doylestown, Pennsylvania 18901-2554

United States

AnMed Health Center

Anderson, South Carolina 29621

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina 29425-8908

United States

Texas Health Research & Education Institute

Dallas, Texas 75231-3815

United States

University of Virginia Medical Center

Charlottesville, Virginia 22908

United States