STOP AF First Post-Approval Study

May 19, 2026 updated by: Medtronic Cardiac Ablation Solutions

STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Active, not recruiting
        • Alaska Heart Institute
    • Connecticut
      • Stamford, Connecticut, United States, 06905-5522
        • Recruiting
        • Cardiology Associates of Fairfield County
        • Contact:
          • Joseph Tiano, MD
        • Principal Investigator:
          • Joseph Tiano, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • BayCare Medical Group Cardiology
        • Contact:
      • Davie, Florida, United States, 33328
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Withdrawn
        • Our Lady of The Lake
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Recruiting
        • Southcoast Health System
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Recruiting
        • Henry Ford Heart & Vascular
        • Contact:
    • Ohio
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Memphis, Tennessee, United States, 38104-6638
        • Withdrawn
        • University of Tennessee Methodist Physicians
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Health Research and Education Institute
        • Contact:

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.

Description

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

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)

April 28, 2022

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 7, 2022

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 AF First 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.

No

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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