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NCT05227053Recruiting

STOP AF First Post-Approval Study

Medtronic Cardiac Ablation Solutions

Start Date

4/28/2022

Completion Date

4/1/2028

Summary

The STOP AF First PAS is a prospective, global, multi-center, observational trial.

Detailed Description

The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-market approval order (P100010/S110) by the U.S. Food and Drug Administration.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Subject has been diagnosed with symptomatic paroxysmal AF * Subject is ≥ 18 years of age or minimum age as required by local regulations * Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System. * Willing 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: History of AF treatment with a class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence1 . Subjects under the following conditions may be included in the study: 1. Temporary treatment with a class I or III AAD (treatment at a therapeutic dose for a period of \<4 weeks prior to the index PVI procedure) 2. Recent treatment with a class I or III AAD (within 6 months of the index PVI procedure) at a dose below therapeutic threshold according to the AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation 3. A subject who has received a chemical cardioversion may be included in the study. This includes a chemical cardioversion prior to enrollment and between enrollment and ablation. * Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL) * Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager * Subject with exclusion criteria required by local law

Interventions

DEVICE

Arctic Front™ Cardiac Cryoablation Catheter

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Conditions

Paroxysmal Atrial Fibrillation

Locations

Alaska Heart Institute

Anchorage, Alaska 99508

United States

Cardiology Associates of Fairfield County

Stamford, Connecticut 06905-5522

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

BayCare Medical Group Cardiology

Clearwater, Florida 33756

United States

Heart Rhythm Solutions

Davie, Florida 33328

United States

Iowa Heart

West Des Moines, Iowa 50266

United States

Our Lady of the Lake

Baton Rouge, Louisiana 70808

United States

Southcoast Health System

North Dartmouth, Massachusetts 02747

United States

Henry Ford Heart & Vascular

Detroit, Michigan 48202-2608

United States

The Lindner Research Center

Cincinnati, Ohio 45219

United States

Stern Cardiovascular Foundation

Germantown, Tennessee 38138

United States

University of Tennessee Methodist Physicians

Memphis, Tennessee 38104-6638

United States

Texas Health Research and Education Institute

Dallas, Texas 75231

United States