New device aims to tame stubborn atrial fibrillation after first ablation fails

NCT ID NCT07298473

Recruiting now Disease control Sponsor: Medtronic Cardiac Ablation Solutions Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests a new catheter system (Sphere-9) for a repeat heart ablation procedure in 400 people whose atrial fibrillation came back after an earlier ablation. The procedure uses radiofrequency and pulsed field energy to correct faulty heart signals. Participants will be followed for 12 months to see if the treatment safely controls their heart rhythm without needing more procedures or strong medications.

What this could mean

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

Active substance: Sphere-9 Catheter and Affera Ablation System (device delivering radiofrequency and pulsed field energy)
What this could lead to: If successful, this could offer a more effective option for people whose atrial fibrillation returns after a first ablation, potentially reducing the need for further procedures or long-term medication.
What could go wrong: This is a non-randomized, single-arm study, so results may be less definitive. Risks include serious complications like stroke, heart block, or esophageal injury. Success depends on individual factors.

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 persistent atrial fibrillation

As listed by the trial registrant

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

ATRIAL FIBRILLATION (AF) PAROXYSMAL ATRIAL FIBRILLATION (PAF) PERSISTENT ATRIAL FIBRILLATION

Contacts and locations

Locations

Adelaide University
RECRUITING

Adelaide, South Australia, 5000, Australia
AdventHealth Cardiovascular Research Institute
NOT_YET_RECRUITING

Orlando, Florida, 32803, United States
Allegheny General Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15212-4756, United States
Cedars Sinai Medical Center
RECRUITING

Los Angeles, California, 90048-1804, United States
Centra Medical Group Stroobants Cardiovascular Center
RECRUITING

Lynchburg, Virginia, 24501, United States
Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States
Clinique Pasteur
NOT_YET_RECRUITING

Toulouse, 31076, France
Hospital of the University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
IKEM - Institut Klinické a Experimentální Medicíny
NOT_YET_RECRUITING

Prague, 140 21, Czechia
Inova Fairfax Hospital
RECRUITING

Falls Church, Virginia, 22042, United States
Inselspital - Universitätsspital Bern
NOT_YET_RECRUITING

Bern, 3010, Switzerland
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)
NOT_YET_RECRUITING

Kansas City, Missouri, 64111, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114-2621, United States
Memorial Health University Medical Center
RECRUITING

Savannah, Georgia, 31404, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
Motol and Homolka University Hospital
NOT_YET_RECRUITING

Prague, 150 30, Czechia
NCH Rooney Heart Institute
RECRUITING

Naples, Florida, 34102, United States
NYU Langone Health
RECRUITING

New York, New York, 10016-4972, United States
Northwell Health Lenox Hill Hospital
RECRUITING

New Hyde Park, New York, 11040-1402, United States
OhioHealth Research and Innovation Institute (OHRI)
RECRUITING

Columbus, Ohio, 43214-3467, United States
Piedmont Heart Institute
RECRUITING

Atlanta, Georgia, 30309, United States
Scripps Green Hospital
NOT_YET_RECRUITING

La Jolla, California, 92037, United States
Sentara Norfolk General Hospital
RECRUITING

Newport News, Virginia, 23606-2981, United States
Texas Cardiac Arrhythmia Research Foundation
RECRUITING

Dallas, Texas, 75226, United States
Texas Health Fort Worth
RECRUITING

Fort Worth, Texas, 76104, United States
The Royal Melbourne Hospital
RECRUITING

Parkville, Victoria, 3050, Australia
Universitair Ziekenhuis Brussel
NOT_YET_RECRUITING

Brussels, 1090, Belgium
University of Alabama at Birmingham (UAB) Hospital
RECRUITING

Birmingham, Alabama, 35233, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232-0019, United States
Westmead Hospital
RECRUITING

Westmead, New South Wales, 2145, Australia

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