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New heart ablation study targets health disparities in minorities

NCT ID NCT07535268

Disease control Sponsor: Vivek Reddy 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a procedure called pulsed field ablation (PFA) to treat atrial fibrillation, a common heart rhythm problem, in patients from racial and ethnic minority groups. About 275 participants will receive the standard PFA treatment using FDA-approved catheters, and researchers will track safety and effectiveness for one year. The goal is to see if this treatment works well in groups that have been underrepresented in past research.

What this could mean

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

Active substance
FARAWAVE Pulsed Field Ablation Catheter (device)
What this could lead to
If successful, this could show that pulsed field ablation is safe and effective for treating atrial fibrillation in minority populations, helping reduce health disparities.
What could go wrong
This is an observational registry, not a randomized trial, so results may be less definitive. The study is relatively small (275 participants) and only follows patients for one year.

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 275 people

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

Started

Mar 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Racial or ethnic minorities defined based on modified National Institutes of Health (NIH) categories: Black or African American, American Indian/Alaska native, Asian, Hawaiian or other Pacific Islander, multiracial or of Hispanic, Latino/Latina origin.

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: * All consecutive patients classified as racial or ethnic minorities undergoing ablation using Boston Scientific FDA approved PFA catheters for AF will be included. * De novo ablation for symptomatic paroxysmal and persistent AF (Age ≥ 18) (unless it is a repeat for a patient whose index procedure is also in the registry) who are deemed to be candidates for AF ablation by the investigator. * Able and willing to participate in baseline and follow up evaluation over the study period * Willing and able to provide informed consent, if applicable. Exclusion Criteria: * Enrolled in an investigational drug or device clinical trial or any other trial with outlined treatment plan * Long standing persistent AF (AF \> 1 year duration) * Repeat ablation, unless index ablation procedure was in the REPRESENT-PF registry * Any known contra-indication to ablation procedure at the discretion of the investigator

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Paroxysmal atrial fibrillation Persistent 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

    2 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

  • The Mount Sinai Hospital

    RECRUITING

    New York, New York, 10030, United States

  • Valley Health System

    RECRUITING

    Winchester, Virginia, 22601, United States

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