ACTIVE_NOT_RECRUITING

Abbott Ventricular Tachycardia PAS

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Study Overview

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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.

Official Title

Abbott Ventricular Tachycardia Post Approval Study

Quick Facts

Study Start:2023-07-24

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05839873

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.

Ages Eligible for Study:7 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Kristin Ruffner, PhD

STUDY_DIRECTOR

Clinical Program Director

Study Locations (Sites)

NCH Healthcare System

Naples, Florida, 34102

United States

St. Vincent Hospital

Indianapolis, Indiana, 46240-0970

United States

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

VA Medical Center Minneapolis

Minneapolis, Minnesota, 55417

United States

Carolinas Medical Center

Charlotte, North Carolina, 28203

United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, 37232

United States

Baylor Scott & White Heart & Vascular Hospital

Dallas, Texas, 75226

United States

University of Utah Hospital

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

Kristin Ruffner, PhD, STUDY_DIRECTOR, Clinical Program Director

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-24

Study Completion Date2026-11

Study Record Updates

Study Start Date2023-07-24

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

Ventricular Tachycardia