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

NCT ID NCT05839873

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

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.

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.

ventricular tachycardia

As listed by the trial registrant

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

VENTRICULAR TACHYCARDIA

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

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