Abbott Ventricular Tachycardia PAS
Key facts
- Where
- Boston, Charleston, Charlotte, Dallas, Indianapolis, Minneapolis, Naples, Nashville, Oklahoma City, Overland Park, and Salt Lake City, United StatesSee the 11 sites
Where in United States
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- Carolinas Medical CenterCharlotte, United StatesNo longer taking part
- Baylor Scott & White Heart & Vascular HospitalDallas, United StatesNo longer taking part
- St Vincent HospitalIndianapolis, United StatesNo longer taking part
- VA Medical Center MinneapolisMinneapolis, United StatesNo longer taking part
- NCH Healthcare SystemNaples, United StatesNo longer taking part
- Vanderbilt Heart & Vascular InstituteNashville, United StatesNo longer taking part
- Integris Baptist Medical CenterOklahoma City, United StatesNo longer taking part
- Kansas City Cardiac Arrhythmia Research FoundationOverland Park, United StatesNo longer taking part
- University of Utah HospitalSalt Lake City, United StatesNo longer taking part
Trial details
- Who runs it
- Abbott Medical Devices
- Trial code
- NCT05839873
- Record updated
- 20 October 2025
- Original description
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.Read full original descriptionShow less
Abbott Ventricular Tachycardia Post Approval Study
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.
Inclusion: 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.
Exclusion: History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure; Active systemic infection; Documented or known intracardiac thrombus or myxoma; Patients with prosthetic valves as the catheter may damage the prosthesis; Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation.