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

NCT ID NCT05839873

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Participants

62 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This clinical investigation will enroll subjects of all genders who have recurrent, drug-refractory, sustained monomorphic ventricular tachycardia in patients with non-ischemic structural heart disease.

Ages

7 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient or legally acceptable representative or parent/guardian (as applicable) must provide written informed consent prior to any clinical investigation-related procedure 2. Subjects who have recurrent, drug-refractory, sustained MMVT with non-ischemic structural heart disease and a clinical decision has been made to use FlexAbility SE for an ablation procedure prior to enrollment in the research study 3. Refractory (i.e. not effective, not tolerated or not desired) to at least one Class I/III anti-arrhythmic medication for treatment of MMVT 4. Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure 5. Able and willing to comply with all study requirements Exclusion Criteria: 1. Documented or known intracardiac thrombus or myxoma 2. Active systemic infection 3. History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure 4. Patients with prosthetic valves as the catheter may damage the prosthesis 5. Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.