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

Ventricular Tachycardia Clinical Trial

— LESS-VT  

Official title:

FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490201
• Other study ID #: SJM-CIP-10138
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: April 11, 2024

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 592
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Market Approved RF Ablation System
Subjects receive ablation using an FDA approved radiofrequency (RF) ablation system.
• FlexAbility SE Ablation Catheter
Subjects receive ablation treatment using an ablation system that is not FDA approved.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Czechia	IKEM	Prague	Central Bohemia
Czechia	Nemocnice Na Homolce	Prague
France	Hopital Haut Leveque	Pessac
Germany	Herzzentrum Leipzig GmbH	Leipzig
Italy	Centro Cardiologico Monzino	Milan
Italy	Ospedale San Raffaele	Milan
Spain	Hospital General Universitario Gregorio Marañón	Madrid
United Kingdom	St. Georges Hospital	London
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Texas Cardiac Arrhythmia	Austin	Texas
United States	Johns Hopkins University Hospital	Baltimore	Maryland
United States	Affinity Cardiovascular Specialists, LLC	Birmingham	Alabama
United States	University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Texas Heart Institute	Houston	Texas
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	USC University Hospital	Los Angeles	California
United States	VA Medical Center Minneapolis	Minneapolis	Minnesota
United States	Vanderbilt Heart and Vascular Institute	Nashville	Tennessee
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	WakeMed Hospital	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California at San Diego (UCSD) Medical Center	San Diego	California
United States	University of Washington	Seattle	Washington
United States	University of South Florida	Tampa	Florida
United States	Memorial Hermann Hospital	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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