Abbott Ventricular Tachycardia PAS

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Device: FlexAbility SE Ablation Catheter

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • Florida
    • Naples, Florida, United States, 34102
      • NCH Healthcare System
  • Indiana
    • Indianapolis, Indiana, United States, 46240-0970
      • St. Vincent Hospital
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kansas City Cardiac Arrhythmia Research Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • VA Medical Center Minneapolis
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • INTEGRIS Baptist Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Heart & Vascular Institute
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Scott & White Heart & Vascular Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This clinical investigation will enroll subjects of all genders who have recurrent, drug-refractory, sustained monomorphic ventricular tachycardia in patients with non-ischemic structural heart disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group; Single Arm Group to receive ablation.	Device: FlexAbility SE Ablation Catheter; Subjects receive ablation treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Kristin Ruffner, PhD, Clinical Program Director

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular
• Other Study ID Numbers: ABT-CIP-10471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No