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Heart rhythm breakthrough? new ablation device shows promise for AFib

NCT ID NCT06676072

Completed Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study tested a new catheter and generator system designed to treat paroxysmal atrial fibrillation (AFib) — a common heart rhythm problem. The device uses pulsed field ablation (PFA) to target and destroy tiny areas of heart tissue causing the irregular rhythm. 188 participants with symptomatic AFib that didn't respond to medication were enrolled. The goal was to see if the procedure is safe and effective at stopping AFib episodes.

What this could mean

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

Active substance

TactiFlex SE ablation catheter and Volt pulsed field ablation generator

What this could lead to

If successful, this could offer a safer, more precise way to treat atrial fibrillation without long-term medication.

What could go wrong

This is a completed early-stage device study with 188 participants. Long-term effectiveness and safety in larger populations are not yet known. Risks include procedure-related complications like bleeding or heart rhythm issues.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation Recurrence

As listed by the trial registrant

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

ATRIAL ARRHYTHMIA ATRIAL FIBRILLATION (AF) DRUG REFRACTORY PAROXYSMAL ATRIAL FIBRILLATION PAROXYSMAL AF

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Bryan Heart Medical Center

    Lincoln, Nebraska, 68506, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Erasmus Medical Center - Thoraxcenter

    Rotterdam, S Holln, 3015 CE, Netherlands

  • HCA Florida Mercy Hospital

    Miami, Florida, 33133, United States

  • Henry Ford Providence Southfield Hospital

    Southfield, Michigan, 48075, United States

  • HonorHealth

    Scottsdale, Arizona, 85258, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist The Woodlands Hospital

    Shenandoah, Texas, 77385, United States

  • KH Wiener Neustadt

    Wiener Neustadt, L Austr, 2700, Austria

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical City Fort Worth

    Fort Worth, Texas, 76104, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10021, United States

  • Ocelot Medical Research Group

    Dallas, Texas, 75230, United States

  • Piedmont Athens Regional Medical Center

    Athens, Georgia, 30606, United States

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308, United States

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The Heart Institute at Virginia Mason

    Seattle, Washington, 98111, United States

  • The Heart Rhythm Center of MS

    Gulfport, Mississippi, 39501, United States

  • Tristar Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48104, United States

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee, 37232, United States

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, Dzukija, 08661, Lithuania

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States