STOP AF First Post-Approval Study

Last updated: April 21, 2025
Sponsor: Medtronic Cardiac Ablation Solutions
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Dysrhythmia

Arrhythmia

Treatment

Arctic Front™ Cardiac Cryoablation Catheter

Clinical Study ID

NCT05227053
STOP AF First PAS
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 availableArctic Front™ cardiac cryoablation catheter System.

  • Willing to comply with study requirements and give informed consent (defined aslegally effective, documented confirmation of a subject's voluntary agreement toparticipate in this clinical study) or authorization per institution andgeographical requirements

Exclusion

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 aperiod 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 PVIprocedure) at a dose below therapeutic threshold according to the AHA/ACC/HRSGuideline 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 enrollmentand 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 forconcurrent enrollment by the global study manager

  • Subject with exclusion criteria required by local law

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Arctic Front™ Cardiac Cryoablation Catheter
Phase:
Study Start date:
April 28, 2022
Estimated Completion Date:
January 31, 2028

Study 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.

Connect with a study center

  • Alaska Heart Institute

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Cardiology Associates of Fairfield County

    Stamford, Connecticut 06905-5522
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • BayCare Medical Group Cardiology

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Heart Rhythm Solutions

    Davie, Florida 33328
    United States

    Active - Recruiting

  • Iowa Heart

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Our Lady of the Lake

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • Southcoast Health System

    North Dartmouth, Massachusetts 02747
    United States

    Active - Recruiting

  • Henry Ford Heart & Vascular

    Detroit, Michigan 48202-2608
    United States

    Active - Recruiting

  • The Lindner Research Center

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Stern Cardiovascular Foundation

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • University of Tennessee Methodist Physicians

    Memphis, Tennessee 38104-6638
    United States

    Active - Recruiting

  • Texas Health Research and Education Institute

    Dallas, Texas 75231
    United States

    Active - Recruiting

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