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STOP AF First Post-Approval Study for Paroxysmal Atrial Fibrillation

This study is looking at the long-term safety and effectiveness of the Arctic Front™ Cardiac Cryoablation Catheter System. This device is used to treat paroxysmal atrial fibrillation (AF), a type of irregular heartbeat. The study aims to see how well the treatment prevents AF, atrial flutter (AFL), and atrial tachycardia (AT) over 36 months, and to track any safety issues for 12 months. You may be able to join if you are 18 or older, have symptomatic paroxysmal AF, and are planning to have a procedure using the Arctic Front™ system. The study is currently unclear on its recruitment status and plans to enroll 200 participants.

Study design
This is a global, multi-center observational study. It plans to enroll 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for freedom from AF/AFL/AT for 36 months, and for safety events for 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05227053

STOP AF First Post-Approval Study

Recruiting
Not specifiedAges 18+Observational
Medtronic Cardiac Ablation Solutions
~200 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Arctic Front™ Cardiac Cryoablation Catheter

At a glance

Recruiting sites
10 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
Measured over 36 months
+1 more outcome measured

Conditions

Paroxysmal Atrial Fibrillation

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Paroxysmal Atrial Fibrillation

NCT05227053

Where you'd take part

This study runs at 13 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • BayCare Medical Group Cardiology

    Clearwater, Floridano site contact published

    Recruiting

  • Cardiology Associates of Fairfield County

    Stamford, Connecticutno site contact published

    Recruiting

  • Heart Rhythm Solutions

    Davie, Floridano site contact published

    Recruiting

  • Henry Ford Heart & Vascular

    Detroit, Michiganno site contact published

    Recruiting

  • Iowa Heart

    West Des Moines, Iowano site contact published

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbiano site contact published

    Recruiting

  • Southcoast Health System

    North Dartmouth, Massachusettsno site contact published

    Recruiting

  • Stern Cardiovascular Foundation

    Germantown, Tennesseeno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Khaldoun Tarakji, MD · STUDY_DIRECTOR · Medtronic CAS Chief Medical Officer

Who to contact

Libby Bergmann
[email protected]
(214) 356-4144
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)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.

  • Freedom from Primary Safety Events12 months

    Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ cardiac cryoablation catheter System through 12-months.