Abbott Ventricular Tachycardia PAS

Description

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.

Conditions

Ventricular Tachycardia

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Study Overview

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Study Details

Study overview

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.

Abbott Ventricular Tachycardia Post Approval Study

Abbott Ventricular Tachycardia PAS

Condition
Ventricular Tachycardia
Intervention / Treatment

-

Contacts and Locations

Aurora

Aurora Denver Cardiology Associates, Aurora, Colorado, United States, 80012

Naples

NCH Healthcare System, Naples, Florida, United States, 34102

Sarasota

Sarasota Memorial Hospital, Sarasota, Florida, United States, 34239

Indianapolis

St. Vincent Hospital, Indianapolis, Indiana, United States, 46240-0970

Overland Park

Kansas City Cardiac Arrhythmia Research Foundation, Overland Park, Kansas, United States, 66211

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Minneapolis

VA Medical Center Minneapolis, Minneapolis, Minnesota, United States, 55417

Charlotte

Carolinas Medical Center, Charlotte, North Carolina, United States, 28203

Oklahoma City

Integris Baptist Medical Center, Oklahoma City, Oklahoma, United States, 73112

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

7 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Kristin Ruffner, PhD, STUDY_DIRECTOR, Clinical Program Director

Study Record Dates

2028-11