Clinical trial NCT03490201: FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study
Official title: FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-04-06
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pivotal medical device study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate of complications
timeFrame: 7 days
measure: Freedom from recurrence of VT
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Affinity Cardiovascular Specialists, LLC
state: Alabama
city: Birmingham
country: United States
facility: University Hospital - Univ. of Alabama at Birmingham (UAB)
state: Alabama
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: San Diego
country: United States
facility: University of California at San Diego (UCSD) Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: VA Medical Center Minneapolis
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Raleigh
country: United States
facility: WakeMed Hospital
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Heart and Vascular Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: The Woodlands
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Prague
country: Czechia
facility: IKEM
state: Central Bohemia
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: London
country: United Kingdom
facility: St. Georges Hospital
Study officials:
affiliation: Abbott
name: Sarah Kammer
role: STUDY_DIRECTOR
References: