Abbott Ventricular Tachycardia PAS

Running, not enrolling

Conditions studied: Ventricular Tachycardia

In brief

This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. This is a prospective, single arm, open-label, multi-center, observational study.

Key facts

Study ID

NCT05839873

Run by

Abbott Medical Devices

People needed

62

Starts

2023-07-24

Expected to finish

2026-11-01

Last updated by the study team

2025-10-20

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient or legally acceptable representative or parent/guardian (as applicable) must provide written informed consent prior to any clinical investigation-related procedure
• 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
• Refractory (i.e. not effective, not tolerated or not desired) to at least one Class I/III anti-arrhythmic medication for treatment of MMVT
• Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure
• Able and willing to comply with all study requirements

You may not qualify if…

• Documented or known intracardiac thrombus or myxoma
• Active systemic infection
• History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure
• Patients with prosthetic valves as the catheter may damage the prosthesis
• Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation

Where it is running

• NCH Healthcare System — Naples, Florida, United States
• St. Vincent Hospital — Indianapolis, Indiana, United States
• Kansas City Cardiac Arrhythmia Research Foundation — Overland Park, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• VA Medical Center Minneapolis — Minneapolis, Minnesota, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt Heart & Vascular Institute — Nashville, Tennessee, United States
• Baylor Scott & White Heart & Vascular Hospital — Dallas, Texas, United States
• University of Utah Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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