FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study

NCT ID: NCT03490201

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 592 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2024-04-11

Brief Summary

This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.

Detailed Description

This is a regulated, prospective, multi-center trial designed to evaluate the safety and effectiveness of the FlexAbility[TM] Ablation Catheter, Sensor Enabled[TM] (FlexAbility SE) catheter to obtain an indication to treat monomorphic ventricular tachycardia (MMVT) in the United States of America (US). The clinical trial has two cohorts: one is a randomized ischemic cardiomyopathy (ICM) cohort and the second is a concurrent single-arm non-ischemic cardiomyopathy (NICM) cohort. Four hundred ten (410) subjects with drug refractory sustained MMVT and ICM and 182 subjects with drug refractory sustained MMVT and NICM will be enrolled at up to 35 centers worldwide. Study subjects who have drug refractory sustained MMVT and ICM will be randomized 1:1 to treatment with the FlexAbility SE catheter ablation system in the Treatment group, or the ThermoCool, ThermoCool NaviStar, or ThermoCool SmartTouch Ablation Catheter from Biosense Webster in the Control group. Since at study start there was no approved device for VT ablation in patients with NICM to use as a comparator, subjects who have drug refractory MMVT and NICM will be treated with the FlexAbility SE catheter ablation system only.

Conditions

Ventricular Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Randomized - Control

Subjects with ICM and randomized to the Control group will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with any of the protocol-specified commercially available ablation catheters indicated for patients with ICM. A protocol-specified commercially available mapping system will be used in conjunction with the control catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure.

Group Type: ACTIVE_COMPARATOR

Market Approved RF Ablation System

Intervention Type: DEVICE

Subjects receive ablation using an FDA approved radiofrequency (RF) ablation system.

Randomized - Treatment

Subjects with ICM and randomized to the Treatment group will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with the investigational FlexAbility SE Catheter. The Ampere Generator, Cool Point Irrigation Pump and the EnSite Precision Cardiac Mapping System or EnSite X EP System will be used in conjunction with the FlexAbility SE catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure.

Group Type: ACTIVE_COMPARATOR

FlexAbility SE Ablation Catheter

Intervention Type: DEVICE

Subjects receive ablation treatment using an ablation system that is not FDA approved.

Non-randomized - Treatment

Subjects with NICM will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with the investigational FlexAbility SE Catheter. The Ampere Generator, Cool Point Irrigation Pump and the EnSite Precision Cardiac Mapping System or EnSite X EP System will be used in conjunction with the FlexAbility SE catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure.

Group Type: EXPERIMENTAL

FlexAbility SE Ablation Catheter

Intervention Type: DEVICE

Subjects receive ablation treatment using an ablation system that is not FDA approved.

Interventions

Market Approved RF Ablation System

Subjects receive ablation using an FDA approved radiofrequency (RF) ablation system.

Intervention Type: DEVICE

FlexAbility SE Ablation Catheter

Subjects receive ablation treatment using an ablation system that is not FDA approved.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Structural heart disease (ischemic or non-ischemic) with one of the following:

• Confirmed diagnosis via echocardiography and/or cardiac CT/MRI [computed tomography/magnetic resonance imaging], or
• Left ventricular ejection fraction (EF) <40% (documented within the last 6 months via echocardiography, or
• Arrhythmogenic RV [right ventricular] cardiomyopathy/dysplasia (per 2010 ARVC/D [arrhythmogenic right ventricular cardiomyopathy/dysplasia] Task Force Criteria).27
• At least one documented episode of sustained MMVT by either EGM [cardiac electrogram] or ECG [electrocardiogram] in the 6 months prior to enrollment
• Implanted with a market released ICD [implantable cardioverter-defibrillator] or CRT-D [cardiac resynchronization therapy-defibrillator] for at least 30 days prior to index ablation procedure
• Refractory (i.e. not effective, not tolerated or not desired) to at least one anti-arrhythmic medication (either amiodarone or sotalol) for treatment of MMVT
• At least 18 years of age
• Informed of the nature of the study, agreed to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical study site.
• Able and willing to comply with all study requirements

Exclusion Criteria

• Implanted with a subcutaneous ICD
• Implanted with a ventricular assist device (VAD) (e.g. TandemHeart)
• Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO)
• Presence of intracardiac thrombus verified via computer tomography (CT), magnetic resonance imaging (MRI), transesophageal echocardiogram (TEE), or transthoracic echocardiogram (TTE) within 48 hours prior to the index ablation procedure or intra-procedure intracardiac echocardiography (ICE)

o For subjects with a history of AF [atrial fibrillation], this verification must be done via TEE or ICE

• ST elevation myocardial infarction (MI) within 60 days prior to index ablation procedure
• Previous cardiac surgery (e.g. ventriculotomy, atriotomy, coronary artery bypass graft), within 60 days prior to index ablation procedure
• Percutaneous coronary intervention (PCI) within 30 days prior to index ablation procedure
• Idiopathic VT
• Incessant VT (continuous sustained VT that promptly recurs despite repeated intervention for termination over ≥3 hours) necessitating immediate treatment or requiring hemodynamic support prior to the ablation procedure
• VT/VF [ventricular tachycardia/ventricular fibrillation] thought to be from channelopathies
• Reversible cause of VT
• Severe aortic stenosis or flail mitral valve
• Mechanical mitral and aortic valve
• History of stroke with modified Rankin scale > 3 (See Appendix C)
• Unstable angina
• Chronic NYHA [New York Heart Association] Class IV heart failure
• Ejection fraction < 15%
• Thrombocytopenia (defined as platelet count <80,000) or coagulopathy
• Contraindication to systemic anticoagulation (i.e. heparin, warfarin, or a direct thrombin inhibitor)
• Women who are pregnant or nursing
• Active uncontrolled infection
• Other anatomic or co morbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirements, or impact the scientific soundness of the study results
• Enrolled in an investigational study evaluating another device or drug that would confound the results of this study
• Have a life expectancy of less than 12 months due to any condition.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Kammer

Role: STUDY_DIRECTOR

Abbott

Locations

Affinity Cardiovascular Specialists, LLC

Birmingham, Alabama, United States

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

USC University Hospital

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

University of California at San Diego (UCSD) Medical Center

San Diego, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Broward General Medical Center

Fort Lauderdale, Florida, United States

Memorial Regional Hospital

Hollywood, Florida, United States

University of South Florida

Tampa, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Johns Hopkins University Hospital

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

VA Medical Center Minneapolis

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

WakeMed Hospital

Raleigh, North Carolina, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia

Austin, Texas, United States

Texas Heart Institute

Houston, Texas, United States

Memorial Hermann Hospital

The Woodlands, Texas, United States

University of Washington

Seattle, Washington, United States

Royal Adelaide Hospital

Adelaide, South Australia, Australia

IKEM

Prague, Central Bohemia, Czechia

Nemocnice Na Homolce

Prague, , Czechia

Hopital Haut Leveque

Pessac, , France

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Ospedale San Raffaele

Milan, , Italy

Centro Cardiologico Monzino

Milan, , Italy

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

St. Georges Hospital

London, , United Kingdom

Countries

United States; Australia; Czechia; France; Germany; Italy; Spain; United Kingdom

Other Identifiers

SJM-CIP-10138

Identifier Type: -

Identifier Source: org_study_id