RecruitingNCT06578104

PULSED AF Post-Approval Study

PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry

Sponsor

Medtronic Cardiac Ablation Solutions

Enrollment

580 participants

Start Date

Nov 4, 2024

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a post-approval registry following people with atrial fibrillation (AF) who receive pulsed field ablation (PFA) — a newer type of heart procedure that uses electrical pulses instead of heat or cold to correct abnormal heart rhythms — using the commercially available PulseSelect system. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with recurring symptomatic paroxysmal (comes and goes) or persistent atrial fibrillation - Your AF has not been adequately controlled by at least one heart rhythm medication - You are scheduled to have pulmonary vein isolation using the PulseSelect PFA system **You may NOT be eligible if...** - You are unable or unwilling to follow study requirements - You have a blood clot in the heart or other contraindications to the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPulseSelect™ PFA system

Ablation using the PulseSelect™ PFA system

Locations(16)

University of South Florida Health (USF)

Tampa, Florida, United States

Pikeville Medical Center

Whitesburg, Kentucky, United States

Southcoast Health System

Fall River, Massachusetts, United States

Beaumont Health System

Royal Oak, Michigan, 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

Duke University Medical Center (DUMC)

Durham, North Carolina, United States

Bethesda North Hospital

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, 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

University of Virginia Medical Center

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06578104

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