Abbott Ventricular Tachycardia PAS

Recruiting

• Conditions: Ventricular Tachycardia
• Interventions: Device: FlexAbility SE Ablation Catheter

• Registration Number: NCT05839873
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-04-21
• Study First Posted: 2023-05-03
• Study Start: 2023-07-24
• Status Verified: 2024-05
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Primary Completion: 2028-08
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Group	FlexAbility SE Ablation Catheter	Single Arm Group to receive ablation.

Primary Outcome Measures

Name	Time	Method
Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure.	12 Month
Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation	12 Month

Trial Locations

Locations (14)

Aurora Denver Cardiology Associates; 🇺🇸 Aurora, Colorado, United States

NCH Healthcare System; 🇺🇸 Naples, Florida, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, 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

Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States

University of Utah Hospital; 🇺🇸 Salt Lake City, Utah, United States