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New heart device tested for long-term relief from AFib

NCT ID NCT06324201

Disease control Sponsor: Heart Rhythm Clinical and Research Solutions, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at the long-term safety and effectiveness of a device called QDOT MICRO, used with VISITAG SURPOINT, to treat a type of irregular heartbeat called paroxysmal atrial fibrillation. About 250 adults who have symptoms that don't get better with medication will be followed for up to 3 years after the procedure. The goal is to see if the device helps keep the heart rhythm normal without causing serious side effects.

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 250 people

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

Started

Feb 2024

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

Study population will consist of patients in the REAL AF registry who have symptomatic PAF and will have, or have undergone, ablation procedures using the QDOT MICRO™ System with VISITAG SURPOINT™ Module

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: 1. Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF 2. 18 years of age or older 3. Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study 4. Willing and able to provide informed consent for this sub-study Exclusion Criteria: 1. Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...) 2. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan 3. Persistent or long-standing persistent AF 4. In the opinion of the investigator, any known contraindication to an ablation procedure

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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

    20 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

  • Allegheny Health

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Arrhythmia Institute at Grandview

    RECRUITING

    Birmingham, Alabama, 35209, United States

  • Bon Secours Medical Group - Richmond Specialty Care

    RECRUITING

    Richmond, Virginia, 23226, United States

  • Centra Health, Inc.dba Stroobants Cardiovascular Center

    RECRUITING

    Lynchburg, Virginia, 24501, United States

  • Community Memorial Health System

    RECRUITING

    Ventura, California, 93003, United States

  • Franciscan Heart and Vascular Associates

    RECRUITING

    Tacoma, Washington, 98401, United States

  • Medical City - HCA

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Mercy Health

    RECRUITING

    Janesville, Wisconsin, 53548, United States

  • Mobile Cardiology Associates

    RECRUITING

    Mobile, Alabama, 36608, United States

  • Multicare Health Systems-Pulse Heart

    RECRUITING

    Puyallup, Washington, 98372, United States

  • Naples Community Hospital

    WITHDRAWN

    Naples, Florida, 34102, United States

  • Norton Heart and Vascular Institute

    RECRUITING

    Louisville, Kentucky, 40205, United States

  • Piedmont Healthcare

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Sarasota Memorial Health

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Sparrow Clinical Research Institute

    RECRUITING

    Lansing, Michigan, 48912, United States

  • The Brigham and Womens Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02115, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Trinity Health-Michigan Heart

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45221, United States

  • University of Pennsylvania (UPENN)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Valley Health System

    RECRUITING

    Winchester, Virginia, 22601, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.