STOP Persistent AF PAS

Last updated: February 11, 2025
Sponsor: Medtronic Cardiac Ablation Solutions
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Dysrhythmia

Treatment

Arctic Front™ Cardiac Cryoablation Catheter System

Clinical Study ID

NCT05005949
STOP Persistent AF PAS
  • Ages > 18
  • All Genders

Study Summary

The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has been diagnosed with persistent AF.

  • Subject is ≥ 18 years of age or minimum age as required by local regulations.

  • Planned pulmonary vein isolation (PVI) procedure using commercially available ArcticFront™ 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:

  • 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 concurrentenrollment by the global study manager.

  • Subject with exclusion criteria required by local law.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Arctic Front™ Cardiac Cryoablation Catheter System
Phase:
Study Start date:
August 19, 2021
Estimated Completion Date:
August 31, 2027

Study Description

The STOP Persistent AF Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The PAS is a prospective, global, multicenter, observational trial. The purpose of the PAS is to describe long-term clinical performance and safety data in the Persistent AF population treated with Arctic Front™ and Freezor™ MAX Families of Cardiac Cryoablation Catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System). This PAS is a condition of the Pre-Market Approval order (P100010/S098) by the U.S. Food and Drug Administration. Up to 400 subjects will be enrolled to ensure 355 are treated. A minimum of 50% of patients will be enrolled and treated in the US. The follow-up duration for this post-approval study will be 36-months.

Connect with a study center

  • Kepler Universitätsklinikum Med Campus III.

    Linz, 4020
    Austria

    Active - Recruiting

  • MVZ CCB Frankfurt und Main Taunus

    Frankfurt am Main, 60431
    Germany

    Active - Recruiting

  • St. Vinzenz-Hospital Köln

    Köln, 50733
    Germany

    Active - Recruiting

  • Städtische Kliniken München GmbH - Klinikum Bogenhausen

    München, 81925
    Germany

    Active - Recruiting

  • Universitaria Pisana - Stabilimento di Cisanello

    Pisa, 56124
    Italy

    Active - Recruiting

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz

    Łódź, 92-213
    Poland

    Site Not Available

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, L14 3PE
    United Kingdom

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Active - Recruiting

  • Cardiology Associates of Fairfield County

    Stamford, Connecticut 06905-5522
    United States

    Active - Recruiting

  • BayCare Medical Group Cardiology

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Heart Rhythms Solutions

    Davie, Florida 33328
    United States

    Active - Recruiting

  • Carle Foundation Hospital

    Urbana, Illinois 61801-2500
    United States

    Site Not Available

  • Henry Ford Heart & Vascular

    Detroit, Michigan 48202-2608
    United States

    Active - Recruiting

  • Spectrum Health Hospitals

    Grand Rapids, Michigan 49525-6427
    United States

    Site Not Available

  • The Lindner Research Center

    Cincinnati, Ohio 45219-2906
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas 78705-1852
    United States

    Active - Recruiting

  • Texas Health Research & Education Institute

    Dallas, Texas 75231
    United States

    Site Not Available

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