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New heart ablation tech under scrutiny: can it tame dangerous rhythms?

NCT ID NCT04088071

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This registry tracks 20,000 people with atrial fibrillation or ventricular arrhythmias who undergo catheter ablation using advanced CARTO mapping technologies. The goal is to see how safe and effective these procedures are in everyday medical practice. Researchers will monitor heart rhythm recurrence and complications for up to a year after the procedure.

What this could mean

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

Active substance
catheter ablation using CARTO technologies (e.g., THERMOCOOL SMARTTOUCH SF, QDOT MICRO, VARIPULSE)
What this could lead to
If successful, this could confirm that modern catheter ablation is a safe and effective way to control heart rhythm disorders, reducing symptoms and improving quality of life.
What could go wrong
This is an observational registry, not a controlled trial, so results may show associations but not prove cause and effect. Risks of ablation include bleeding, infection, and heart rhythm complications.

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 20,000 people

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

Started

Jan 2018

Expected to finish

Dec 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 consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation in the REAL AF Cohort and adults age 18 years or older with documented ventricular arrhythmia appropriate for catheter ablation in the CORE VA Cohort.

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.

REAL AF Cohort Inclusion Criteria: * Symptomatic PAF (AF episode terminate spontaneously within 7 days) or PsAF (AF sustained beyond 7 days, but less than 365 days) subjects who, in the opinion of the investigator, are candidates for catheter ablation. * \>18 years of age. * Will be treated with Biosense Webster Inc. ablation technologies * All AF ablations performed with BWI catheters are included. This includes repeat ablations where the index procedure was performed with a non-BWI catheter. * Able and willing to participate in baseline and follow up evaluations * Willing and able to provide informed consent, if applicable. Exclusion Criteria: * Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan * Long-standing persistent AF (AF greater than one year) * In the opinion of the investigator, any known contraindication to an ablation procedure CORE VA Cohort Inclusion Criteria: * Documented ventricular arrhythmia appropriate for catheter ablation. * \>18 years of age. * Will be treated with Biosense Webster Inc. ablation technologies * Able and willing to participate in baseline and follow up evaluations * Willing and able to provide informed consent, if applicable. Exclusion Criteria: * Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan. * 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 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 Ventricular arrhythmia

How to take part

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

  1. The places running it

    66 sites in 2 countries. 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

  • Alberta Health

    RECRUITING

    Edmonton, Alberta, T6G2B7, Canada

  • Allegheny Health Network

    RECRUITING

    Pittsburgh, Pennsylvania, 15222, United States

  • Arrhythmia Research Group

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • Ascension Sacred Heart

    RECRUITING

    Pensacola, Florida, 32504, United States

  • Ascension St. Vincent's

    RECRUITING

    Jacksonville, Florida, 32204, United States

  • Ascension St. Vincent's Hospital

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Baptist Health Louisville

    RECRUITING

    Saint Matthews, Kentucky, 40207, United States

  • Baycare Health System

    RECRUITING

    Winterhaven, Florida, 33881, United States

  • Baycare Health Tampa

    RECRUITING

    Tampa, Florida, 33606, United States

  • Baylor Scott & White Research Institute

    RECRUITING

    Dallas, Texas, 75204, United States

  • Bon Secours St. Marys

    RECRUITING

    Midlothian, Virginia, 23114, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CJW Medical Center

    RECRUITING

    Richmond, Virginia, 23261, United States

  • Capitol CArdiology

    RECRUITING

    Lanham, Maryland, 20706, United States

  • Cardiology Associates of Mobile

    RECRUITING

    Mobile, Alabama, 36695, United States

  • Cardiovascular Associates of the Delaware Valley

    RECRUITING

    Haddon Heights, New Jersey, 08035, United States

  • Carolina Cardiology Associates and OnSite Clinical Solutions

    TERMINATED

    Rock Hill, South Carolina, 29732, United States

  • Centra Health, Inc. dba Stroobants Cardiovascular Center

    RECRUITING

    Lynchburg, Virginia, 24501, United States

  • Colorado Heart and Vascular

    RECRUITING

    Golden, Colorado, 80401, United States

  • Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH)

    RECRUITING

    New York, New York, 10032, United States

  • Community Memorial Hospital

    RECRUITING

    Ventura, California, 93303, United States

  • CoxHealth

    RECRUITING

    Springfield, Missouri, 65807, United States

  • Crouse Health System and Crouse Medical Practice

    RECRUITING

    Syracuse, New York, 13210, United States

  • Grandview Medical Center

    RECRUITING

    Birmingham, Alabama, 35243, United States

  • HCA Florida Mercy Hospital

    RECRUITING

    Miami, Florida, 33133, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Keck School of Medicine

    RECRUITING

    Los Angeles, California, 90033, United States

  • Lancaster General Hospital

    RECRUITING

    Lancaster, Pennsylvania, 17602, United States

  • Lovelace Health System

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • Maine Medical Center

    RECRUITING

    Portland, Maine, 04102, United States

  • McLaren Greater Lansing

    ACTIVE_NOT_RECRUITING

    Lansing, Michigan, 48910, United States

  • Medical City Dallas Hospital

    RECRUITING

    Dallas, Texas, 75320, United States

  • Memorial Health University Medical Center

    RECRUITING

    Savannah, Georgia, 31404, United States

  • MercyHealth

    RECRUITING

    Janesville, Wisconsin, 53548, United States

  • Michigan Heart

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Midwest Cardiovascular Institute

    RECRUITING

    Naperville, Illinois, 60540, United States

  • Mission Hospital

    RECRUITING

    Asheville, North Carolina, 28801, United States

  • Mississippi Baptist Medical Center

    RECRUITING

    Jackson, Mississippi, 39202, United States

  • Mount Carmel Columbus Cardiology Consultants

    RECRUITING

    Columbus, Ohio, 43213, United States

  • MultiCare Institute for Research & Innovation

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Naples Community Hospital

    RECRUITING

    Naples, Florida, 34101, United States

  • Northshore University Health System

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Norton Heart Specialists

    RECRUITING

    Louisville, Kentucky, 40205, United States

  • Novant Health Forsyth Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Nuvance Health

    RECRUITING

    Poughkeepsie, New York, 12601, United States

  • Oklahoma Heart Hospital

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Piedmont Healthcare

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Pima Heart and Vascular

    RECRUITING

    Tucson, Arizona, 85741, United States

  • Prairie Education and Research

    RECRUITING

    Springfield, Illinois, 62704, United States

  • Santa Barbara Cottage Hospital

    TERMINATED

    Santa Barbara, California, 93105, United States

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • South Denver Cardiology

    RECRUITING

    Littleton, Colorado, 80120, United States

  • Southlake Regional Health Centre

    RECRUITING

    Newmarket, Ontario, L3Y2P6, Canada

  • Sparrow Clinical Research

    RECRUITING

    Lansing, Michigan, 48912, United States

  • St. Mark's Hospital

    RECRUITING

    Salt Lake City, Utah, 84124, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Medical Center of Aurora

    RECRUITING

    Aurora, Colorado, 80012, United States

  • The Queen's Medical Center

    RECRUITING

    Honolulu, Hawaii, 97813, United States

  • University HealthCare Alliance

    COMPLETED

    Walnut Creek, California, 94598, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45202, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Missouri

    RECRUITING

    Columbia, Missouri, 65212, United States

  • University of Pennsylvania, Penn Presbyterian Medical Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Upstate Cardiology

    RECRUITING

    Greenville, South Carolina, 29607, United States

  • Valley Health

    RECRUITING

    Winchester, Virginia, 22601, United States

  • Valley Heart Rhythm Specialists

    RECRUITING

    Chandler, Arizona, 85224, United States

  • WellSpan Health

    RECRUITING

    York, Pennsylvania, 17403, United States

  • William Beaumont Hospital

    RECRUITING

    Royal Oak, Michigan, 48073, United States

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