Balloon catheter aims to zap away irregular heartbeat

NCT ID NCT03683030

Completed Disease control Sponsor: Biosense Webster, Inc. Source: ClinicalTrials.gov ↗

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.

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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

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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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