Abbott Ventricular Tachycardia PAS

Last updated: October 15, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Disease

Fast Heart Rate (Tachycardia)

Chest Pain

Treatment

FlexAbility SE Ablation Catheter

Clinical Study ID

NCT05839873
ABT-CIP-10471
  • Ages > 7
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patient or legally acceptable representative or parent/guardian (as applicable) mustprovide written informed consent prior to any clinical investigation-relatedprocedure

  2. Subjects who have recurrent, drug-refractory, sustained MMVT with non-ischemicstructural heart disease and a clinical decision has been made to use FlexAbility SEfor 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 ClassI/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

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 AblationProcedure

  4. Patients with prosthetic valves as the catheter may damage the prosthesis

  5. Unable to receive heparin or an acceptable alternative to achieve adequateanticoagulation

Study Design

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: FlexAbility SE Ablation Catheter
Phase:
Study Start date:
July 24, 2023
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Aurora Denver Cardiology Associates

    Aurora, Colorado 80012
    United States

    Site Not Available

  • NCH Healthcare System

    Naples, Florida 34102
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Site Not Available

  • NCH Healthcare System

    Naples 4165565, Florida 4155751 34102
    United States

    Site Not Available

  • St. Vincent Hospital

    Indianapolis, Indiana 46240-0970
    United States

    Site Not Available

  • St. Vincent Hospital

    Indianapolis 4259418, Indiana 4921868 46240-0970
    United States

    Site Not Available

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park 4276873, Kansas 4273857 66211
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • VA Medical Center Minneapolis

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • VA Medical Center Minneapolis

    Minneapolis 5037649, Minnesota 5037779 55417
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte 4460243, North Carolina 4482348 28203
    United States

    Site Not Available

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Integris Baptist Medical Center

    Oklahoma City 4544349, Oklahoma 4544379 73112
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt Heart & Vascular Institute

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Baylor Scott & White Heart & Vascular Hospital

    Dallas, Texas 75226
    United States

    Site Not Available

  • Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor Scott & White Heart & Vascular Hospital

    Dallas 4684888, Texas 4736286 75226
    United States

    Site Not Available

  • University of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Utah Hospital

    Salt Lake City 5780993, Utah 5549030 84132
    United States

    Site Not Available

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