Abbott Ventricular Tachycardia PAS

Last updated: April 2, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Arrhythmia

Dysrhythmia

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: 150
Treatment Group(s): 1
Primary Treatment: FlexAbility SE Ablation Catheter
Phase:
Study Start date:
July 24, 2023
Estimated Completion Date:
November 30, 2028

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

    Active - Recruiting

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • St. Vincent Hospital

    Indianapolis, Indiana 46240-0970
    United States

    Active - Recruiting

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • VA Medical Center Minneapolis

    Minneapolis, Minnesota 55417
    United States

    Active - Recruiting

  • Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Baylor Scott & White Heart & Vascular Hospital

    Dallas, Texas 75226
    United States

    Active - Recruiting

  • Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

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