Heart rhythm device under the microscope: new study tracks Long-Term safety

NCT ID NCT05839873

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 62 people with non-ischemic structural heart disease who have recurrent, drug-resistant ventricular tachycardia. They are treated with the FlexAbility SE ablation catheter, which uses heat to destroy small areas of heart tissue causing the abnormal rhythm. Researchers will track serious complications and whether patients remain free of VT, death, or need a heart transplant for one year after the procedure.

What this could mean

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

Active substance

FlexAbility SE Ablation Catheter (device used to destroy heart tissue causing abnormal rhythms)

What this could lead to

If successful, this could confirm that the FlexAbility SE catheter is a safe and effective option for controlling ventricular tachycardia in patients with non-ischemic structural heart disease.

What could go wrong

This is an observational post-approval study with only 62 participants and no comparison group, so results may not apply to all patients. Risks include procedure-related serious adverse events and VT recurrence.

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.

ventricular tachycardia

As listed by the trial registrant

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

Contacts and locations

Locations

  • Baylor Scott & White Heart & Vascular Hospital

    Dallas, Texas, 75226, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112, United States

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • NCH Healthcare System

    Naples, Florida, 34102, United States

  • St. Vincent Hospital

    Indianapolis, Indiana, 46240-0970, United States

  • University of Utah Hospital

    Salt Lake City, Utah, 84132, United States

  • VA Medical Center Minneapolis

    Minneapolis, Minnesota, 55417, United States

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee, 37232, United States