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New catheter treatment for irregular heartbeat under Long-Term review

NCT ID NCT07227532

Disease control Sponsor: Biosense Webster, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 01, 2026 · Updated 5 times

Summary

This study is checking the long-term safety and effectiveness of the VARIPULSE catheter, a device already approved by the FDA, for treating people with a type of irregular heartbeat called paroxysmal atrial fibrillation. About 276 participants who have symptoms and haven't responded well to medication will be enrolled. The main goals are to track any serious side effects within a week of the procedure and to see how well the treatment prevents abnormal heart rhythms over time.

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

About 276 people

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

Started

Oct 2025

Expected to finish

Dec 2030

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.

Ages

22 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: * Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF * Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD) * Willing and capable of providing consent * Able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: * Previously diagnosed with persistent or long-standing persistent AF (more than \[\>\] 7 days in duration) * Previous surgical or catheter ablation for AF * Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF * Current enrollment in an investigational study evaluating another device or drug * Life expectancy less than 12 months * Any contraindications as defined in the Protocol

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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.

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

    22 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

  • Albert Einstein College Of Medicine - Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Aurora Denver Cardiology Associates

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • Baylor Scott and White Research Institute

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Community Memorial Hospital

    RECRUITING

    Ventura, California, 93003, United States

  • Edward Hospital Midwest Cardiovascular Institute

    RECRUITING

    Naperville, Illinois, 60540, United States

  • HCA Florida Mercy Hospital

    RECRUITING

    Miami, Florida, 33133, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mercy Hospital

    RECRUITING

    Janesville, Wisconsin, 53548, United States

  • Northwell Health Physician Partners Cardiology

    RECRUITING

    Lake Success, New York, 11042, United States

  • OC Memorial

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Orlando Health Heart and Vascular Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Phoenix Cardiovascular Research Group

    RECRUITING

    Phoenix, Arizona, 85018, United States

  • Springfield Medical Center

    RECRUITING

    Springfield, Ohio, 45504, United States

  • Texas Cardiac Arrhythmia Research Foundation

    RECRUITING

    Austin, Texas, 78705, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • The Kansas City Heart Rhythm Institute

    RECRUITING

    Overland Park, Kansas, 66211, United States

  • Trinity Health

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Tucson Medical Center Pima Heart and Vascular

    RECRUITING

    Tucson, Arizona, 85704, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Winchester Medical Center

    RECRUITING

    Winchester, Virginia, 22601, United States

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