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Freezing away AF: new study tracks 3-Year success of cryoablation

NCT ID NCT05227053

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This study follows 200 people with paroxysmal atrial fibrillation (AF) who undergo a procedure using a freezing catheter to isolate the pulmonary veins. The goal is to see how many remain free from AF, atrial flutter, or atrial tachycardia for up to 3 years, and to track safety events over 12 months. It is an observational, post-approval study, meaning the device is already approved and in use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Arctic Front™ cardiac cryoablation catheter (a device that freezes heart tissue to stop abnormal electrical signals)
What this could lead to
If successful, this could confirm that cryoablation is a safe and effective long-term option for controlling paroxysmal atrial fibrillation.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. Risks include rare but serious complications like heart damage or stroke from the procedure.

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 200 people

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

Started

Apr 2022

Expected to finish

Apr 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.

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 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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

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

Paroxysmal atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alaska Heart Institute

    ACTIVE_NOT_RECRUITING

    Anchorage, Alaska, 99508, United States

  • BayCare Medical Group Cardiology

    RECRUITING

    Clearwater, Florida, 33756, United States

  • Cardiology Associates of Fairfield County

    RECRUITING

    Stamford, Connecticut, 06905-5522, United States

  • Heart Rhythm Solutions

    RECRUITING

    Davie, Florida, 33328, United States

  • Henry Ford Heart & Vascular

    RECRUITING

    Detroit, Michigan, 48202-2608, United States

  • Iowa Heart

    RECRUITING

    West Des Moines, Iowa, 50266, United States

  • MedStar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Our Lady of the Lake

    WITHDRAWN

    Baton Rouge, Louisiana, 70808, United States

  • Southcoast Health System

    RECRUITING

    North Dartmouth, Massachusetts, 02747, United States

  • Stern Cardiovascular Foundation

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Texas Health Research and Education Institute

    RECRUITING

    Dallas, Texas, 75231, United States

  • The Lindner Research Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Tennessee Methodist Physicians

    WITHDRAWN

    Memphis, Tennessee, 38104-6638, United States

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