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Freezing heart tissue to stop AFib: new device under study

NCT ID NCT06170606

Disease control Sponsor: Boston Scientific Corporation 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 28, 2026 · Updated 6 times

Summary

This study tests a device that freezes small areas of heart tissue to treat paroxysmal atrial fibrillation (AFib), a condition where the heart beats irregularly. About 200 people with AFib that hasn't responded to medication will receive the procedure. Researchers will track safety and effectiveness for 12 months, looking for serious side effects and whether the heart stays in normal rhythm.

What this could mean

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

Active substance
Cardiac Cryoablation System (device that freezes heart tissue to stop abnormal signals)
What this could lead to
If successful, this could offer a safe, effective way to control paroxysmal atrial fibrillation without needing lifelong medication.
What could go wrong
This is a single-arm study with no comparison group, so results may be less definitive. Risks include serious complications like stroke, heart damage, or blood clots.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

200 people

The number who actually took part.

Started

Jun 2024

Finished

May 2026

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.

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: * Subjects indicated for drug refractory, recurrent symptomatic PAF treatment with the Cryoablation System, per physician's medical judgement, and as per standard of care * Subjects who are willing and capable of providing informed consent; * Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center; Exclusion Criteria: * Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU as legally approved conditions; * Any prior LA ablation; * Known or pre-existing severe PV Stenosis; * Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings); * Presence of any pulmonary vein stents; * Subjects with active systemic infection; * Subject is unable or not willing to complete follow-up visits and examination for the duration of the study;- Subjects with life expectancy ≤ 1 year per investigator's medical judgement; * Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);

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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

Contacts and locations

Locations

  • Aurora Health

    Grafton, Wisconsin, 53024, United States

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006, United States

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242, United States

  • Intermountain Platte Valley Hospital

    Brighton, Colorado, 80601, United States

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297, United States

  • Pima Heart & Vascular Clinical Research

    Tucson, Arizona, 85718, United States

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203, United States

  • St. Joseph's Hospital/BayCare Medical Group

    Tampa, Florida, 33607, United States

  • Torrance Memorial Medical Center

    Torrance, California, 90505, United States

  • University of Texas Medical Branch - Galveston

    Galveston, Texas, 77555, United States

  • Valley View Hospital

    Glenwood Springs, Colorado, 81601, United States

More trials for these conditions

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