STOP Persistent AF PAS

May 19, 2026 updated by: Medtronic Cardiac Ablation Solutions

STOP Persistent AF Post-Approval Study, a Sub-study to the Cryo Global Registry

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Kepler Universitätsklinikum Med Campus III.
  • Germany
      • Cologne, Germany, 50733
        • St. Vinzenz-Hospital Köln
      • Frankfurt am Main, Germany, 60431
        • MVZ CCB Frankfurt und Main Taunus
      • München, Germany, 81925
        • Städtische Kliniken München GmbH - Klinikum Bogenhausen
  • Italy
      • Pisa, Italy, 56124
        • Universitaria Pisana - Stabilimento di Cisanello
  • Poland
      • Lodz, Poland, 92-213
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz
  • United Kingdom
      • Liverpool, United Kingdom, L14 3PE
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • Stamford, Connecticut, United States, 06905-5522
        • Cardiology Associates of Fairfield County
    • Florida
      • Clearwater, Florida, United States, 33756
        • BayCare Medical Group Cardiology
      • Davie, Florida, United States, 33328
        • Heart Rhythms Solutions
    • Illinois
      • Urbana, Illinois, United States, 61801-2500
        • Carle Foundation Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Henry Ford Heart & Vascular
      • Grand Rapids, Michigan, United States, 49525-6427
        • Spectrum Health Hospitals
    • Ohio
      • Cincinnati, Ohio, United States, 45219-2906
        • The Lindner Research Center
    • Texas
      • Austin, Texas, United States, 78705-1852
        • Texas Cardiac Arrhythmia Research Foundation
      • Dallas, Texas, United States, 75231
        • Texas Health Research & Education Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for a pulmonary vein ablation with the Arctic Front™ Cardiac Cryoablation Catheter System may be approached regarding enrollment in this study.

Description

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 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
Time Frame: 36 months
Estimate the 36-month freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System.
36 months
Freedom from Primary Safety Events
Time Frame: 12 months
Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12-months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Ablation Solutions

Investigators

  • Study Director: Khaldoun Tarakji, MD, Medtronic CAS Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2021

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOP Persistent AF PAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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