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

NCT03490201 | Completed DMC FDA Device

• 1 other identifier: SJM-CIP-10138
• Study Type: interventional
• Target: 592
• Locations: 8 countries
• Sites: 32

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.

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• Rate of complications

  The primary safety endpoint is a composite of cardiovascular-related and procedure-related major complications through 7 days post index ablation procedure.

  7 days

• Freedom from recurrence of VT

  The primary effectiveness endpoint is freedom from recurrent sustained MMVT at 6 months and a new or increased dose Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure.

  6 months

Study Arms (3)

Randomized - Control

ACTIVE COMPARATOR

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.

Device: Market Approved RF Ablation System

Randomized - Treatment

ACTIVE COMPARATOR

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.

Device: FlexAbility SE Ablation Catheter

Non-randomized - Treatment

EXPERIMENTAL

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.

Device: FlexAbility SE Ablation Catheter

Interventions

Market Approved RF Ablation System DEVICE

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

Randomized - Control

FlexAbility SE Ablation Catheter DEVICE

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

Non-randomized - Treatment; Randomized - Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (32)

Affinity Cardiovascular Specialists, LLC

Birmingham, Alabama, 35243, United States

Location

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

Birmingham, Alabama, 35249, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

University of California at San Diego (UCSD) Medical Center

San Diego, California, 92103, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33020, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

VA Medical Center Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

WakeMed Hospital

Raleigh, North Carolina, 27610, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, 37240, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

The Woodlands, Texas, 77380, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

IKEM

Prague, Central Bohemia, 14021, Czechia

Location

Nemocnice Na Homolce

Prague, 15030, Czechia

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

St. Georges Hospital

London, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Kammer

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects are blinded to the randomization assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pivotal medical device study

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: April 6, 2018
• Study Start: June 1, 2018
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); FR (1); US (23); IT (2); ES (1); CZ (2); GB (1); AU (1)