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Clinical Trials in the USA / NCT05839873
Active, not recruiting Observational

Abbott Ventricular Tachycardia PAS

NCT05839873 · tracked via the Priya Life Science USA tracker
Sponsor
Abbott Medical Devices
Phase
Observational
Started
2023-07-24
Last updated
2025-10-20

Condition(s) studied

Ventricular Tachycardia

Investigational drug(s) / intervention(s)

FlexAbility SE Ablation Catheter

FlexAbility SE Ablation Catheter: Subjects receive ablation treatment.

Study summary

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.

Eligibility

Sex
ALL
Min age
7 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (11)

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

More Abbott Medical Devices trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05839873 on ClinicalTrials.gov ↗ ← All trials in the USA