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

Completed · Not applicable

Conditions studied: Ventricular Tachycardia

In brief

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.

Key facts

Study ID

NCT03490201

Run by

Abbott Medical Devices

People needed

592

Starts

2018-06-01

Expected to finish

2024-04-11

Last updated by the study team

2025-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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