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Freezing away heart flutters: new study tests Long-Term control of persistent AF

NCT ID NCT05005949

Disease control Sponsor: Medtronic Cardiac Ablation Solutions Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study looks at a procedure called cryoablation that uses a freezing balloon to destroy tiny areas of heart tissue causing an irregular heartbeat (persistent atrial fibrillation). About 400 adults with this condition will be followed for up to 3 years to see how well the treatment prevents the abnormal rhythm from coming back and to check for any safety issues. The goal is to control the disease, not cure it, since ongoing management may still be needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Persistent atrial fibrillation

Contacts and locations

Locations

  • BayCare Medical Group Cardiology

    Clearwater, Florida, 33756, United States

  • Cardiology Associates of Fairfield County

    Stamford, Connecticut, 06905-5522, United States

  • Carle Foundation Hospital

    Urbana, Illinois, 61801-2500, United States

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz

    Lodz, 92-213, Poland

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Heart Rhythms Solutions

    Davie, Florida, 33328, United States

  • Henry Ford Heart & Vascular

    Detroit, Michigan, 48202-2608, United States

  • Kepler Universitätsklinikum Med Campus III.

    Linz, 4020, Austria

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, L14 3PE, United Kingdom

  • MVZ CCB Frankfurt und Main Taunus

    Frankfurt am Main, 60431, Germany

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49525-6427, United States

  • St. Vinzenz-Hospital Köln

    Cologne, 50733, Germany

  • Städtische Kliniken München GmbH - Klinikum Bogenhausen

    München, 81925, Germany

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705-1852, United States

  • Texas Health Research & Education Institute

    Dallas, Texas, 75231, United States

  • The Lindner Research Center

    Cincinnati, Ohio, 45219-2906, United States

  • Universitaria Pisana - Stabilimento di Cisanello

    Pisa, 56124, Italy

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