Who is eligible for clinical trial NCT05839873?

Participants must meet protocol criteria for Ventricular Tachycardia. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05839873 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-10-15

Abbott Ventricular Tachycardia PAS (NCT05839873)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Abbott Medical Devices

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (6 items).

Location: NCH Healthcare System — Naples, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (11 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗