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New heart catheter shows promise for AFib patients

NCT ID NCT06144632

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special catheter system to treat people with a type of irregular heartbeat called paroxysmal atrial fibrillation (PAF) that didn't get better with medication. The treatment uses heat energy to isolate the veins that trigger the abnormal rhythm. The study included 237 participants and measured how safe the procedure was and how well it prevented heart rhythm problems 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

237 people

The number who actually took part.

Started

Dec 2023

Finished

Oct 2025

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 to 75 years

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: * Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) with (a) at least two symptomatic atrial fibrillation (AF) episodes within last six months from enrollment and (b) at least one AF episode electrocardiographically documented by electrocardiogram (ECG); transtelephonic monitoring (TTM), Holter monitor, telemetry strip or implanted device within 12 months prior to enrollment * Failed at least one antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable side effects to the AAD, or contraindication to the AAD * Willing and capable of providing consent * Able and willing to comply with all pre-, post- and follow-up testing and requirements Exclusion Criteria: * AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera) * Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration) * Previous left atrium (LA) ablation or surgery * Participants known to require ablation outside the pulmonary vein (PV) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia, and Wolff-Parkinson-White), except cavotricuspid isthmus (CTI) lines for the ablation of typical right atrial flutter * Documented severe dilatation of the LA (left anterior descending artery \[LAD\] \>50mm) antero-posterior diameter on imaging within 6 months prior to enrollment * Documented LA thrombus by imaging within 48 hours of the procedure * Documented severely compromised left ventricular ejection fraction (LVEF less than \[\<\] 40 percent \[%\]) by imaging within 6 months prior to enrollment * Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV * History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin) except subjects with prior left atrial appendage closure * Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 12 months * Participants with unstable angina, percutaneous coronary intervention or acute myocardial infarction within 2 months * Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days) * Valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve) * Unstable angina within 6 months * Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months * Significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms * Significant congenital anomaly (for example, atrial septal defects \[ASDs\]) including repaired defects or medical problem that in the opinion of the investigator would preclude enrollment in this study * Prior diagnosis of pulmonary vein stenosis * Pre-existing hemi diaphragmatic paralysis * Acute illness, active systemic infection, or sepsis * Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation * Severe mitral regurgitation (Regurgitant volume greater than or equal to \[\>=\] 60 milli liter (mL)/beat, Regurgitant fraction \>= 50%, and/or Effective regurgitant orifice area \>= 0.40 cm\^2) * Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD), recently implanted (within 6 months) left atrial appendage occlusion (LAAO) device or other implanted metal cardiac device within cardiac space that may interfere with the energy field created during the ablation procedure * Presence of a condition that precludes vascular access * Current enrollment in an investigational study evaluating another device or drug * Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation * Life expectancy less than 12 months * Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)

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Conditions

The condition(s) this trial relates to.

paroxysmal atrial fibrillation

As listed by the trial registrant

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

Drug refractory paroxysmal atrial fibrillation

Contacts and locations

Locations

  • Ascension St. Vincent's

    Jacksonville, Florida, 32204, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

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

    Plano, Texas, 75093, United States

  • Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey, 08035, United States

  • Georgia Arrhythmia Consultants and Research Institute

    Macon, Georgia, 31201, United States

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • HCA Florida JFK Hospital

    Atlantis, Florida, 33462, United States

  • HCA Florida Mercy Hospital

    Miami, Florida, 33133, United States

  • Keck School of Medicine of USC

    Los Angeles, California, 90033, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Massachusetts General

    Boston, Massachusetts, 02114, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Methodist Texsan

    San Antonio, Texas, 78201, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Norton Heart Specialist

    Louisville, Kentucky, 40205, United States

  • Ohio Health Research Institute

    Columbus, Ohio, 43214, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • The Kansas City Heart Rhythm Institute

    Overland Park, Kansas, 66211, United States

  • Trident Medical Center

    North Charleston, South Carolina, 29406, United States

  • Trinity Health Michigan Heart - Ann Arbor Campus

    Ypsilanti, Michigan, 48197, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

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