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Balloon catheter aims to zap away irregular heartbeat

NCT ID NCT03683030

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tested a special balloon catheter that uses radiofrequency energy to destroy tiny areas of heart tissue causing irregular heartbeats in people with symptomatic paroxysmal atrial fibrillation. The study enrolled 397 adults who had not responded to medication. The goal was to see if the device is safe and can stop arrhythmia episodes for up to a year.

What this could mean

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

Active substance
Multi-electrode radiofrequency balloon catheter (HELIOSTAR)
What this could lead to
If successful, this device could offer a new, effective option to control atrial fibrillation without long-term medication.
What could go wrong
This is a device study, and risks include serious complications like stroke or heart damage. Success depends on long-term freedom from arrhythmia, which may not be achieved for everyone.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

397 people

The number who actually took part.

Started

Oct 2018

Finished

Feb 2022

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.

Key Inclusion Criteria: * Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation. 1. At least two symptomatic AF episodes within last six months from enrollment. 2. At least one ectrocardiographically documented AF episode within twelve (12) months prior to enrollment. * Failed at least one Class I or Class III antiarrhythmic drug. * Age 18 -75 years. Key Exclusion Criteria: * AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. * Previous surgical or catheter ablation for AF. * Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF \> 7 days. * Any percutaneous coronary intervention within the past 2 months. * Valve repair or replacement or presence of a prosthetic valve. * Any carotid stenting or endarterectomy within the past 6 months. * Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months. * Documented left atrium (LA) thrombus within 1 day prior to the index procedure. * LA antero posterior diameter \> 50 mm. * Left Ventricular Ejection Fraction (LVEF) \< 40%. * Contraindication to anticoagulation (e.g., heparin). * Myocardial infarction within the past 2 months. * Documented thromboembolic event (including transient ischemic attack) within the past 12 months. * Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV. * Awaiting cardiac transplantation or other cardiac surgery within the next 12 months. * Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD). * Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation. * Life expectancy or other disease processes likely to limit survival to less than 12 months.

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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

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32804., United States

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207, United States

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, Texas, 75093, United States

  • CHI Baylor St. Lukes Medical Center

    Houston, Texas, 77030, United States

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901, United States

  • Emory St Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92618, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inova Health Care Services

    Falls Church, Virginia, 22042, United States

  • Kansas City Arrhythmia Research

    Overland Park, Kansas, 66215, United States

  • Kettering Medical Center

    Kettering, Ohio, 45429, United States

  • Lenox Hill Hospital - Northwell Health

    New York, New York, 10075, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Med Center of the Rockies

    Loveland, Colorado, 80538, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Mercy General Hospital

    Sacramento, California, 95819, United States

  • Methodist Texsan Hospital

    San Antonio, Texas, 78201, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Oklahoma Heart

    Tulsa, Oklahoma, 74101, United States

  • Ospedale "F. Miulli"

    Bari, Italy

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018, United States

  • Piedmont Hospital

    Atlanta, Georgia, 30309, United States

  • Policlinico Di San Donato Milanese

    Milanesi, MI, Italy

  • Ruijin Hospital

    Rui Jin Er Road, Shanghai Municipality, 200025, China

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 92618, United States

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310020, China

  • Spectrum Health System

    Grand Rapids, Michigan, 49503, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The Valley Hospital

    Ridgewood, New Jersey, 07450, United States

  • Trident Medical Center

    Charleston, South Carolina, 29406, United States

  • University Of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520, United States

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