Clinical trial NCT02130765: Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia
Official title: Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Monomorphic Ventricular Tachycardia
Keywords: Monomorphic Ventricular Tachycardia
Ischemic
Non-ischemic
Catheter Ablation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-05-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia \[MMVT\] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.

Detailed description: Approximately 50 centers in the United States (US) will participate in the study. Additional centers outside the US may be considered, as necessary. The anticipated enrollment duration is 48-60 months.

Eligibility criteria: Inclusion Criteria:

* Patient is receiving a new St.Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) or SJM Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implant, which has study required programing capabilities and is appropriate for remote monitoring. Subjects who have received the ICD / CRT-D up to 90 days prior to enrollment are also eligible.
* Patient who has a high risk of ICD shock as shown by at least one documented Monomorphic VT (MMVT)\*\* by one or more of the following:

Spontaneous MMVT or Inducible MMVT during electrophysiology (EP) Study or Inducible MMVT during Non-Invasive Programmed Stimulation (NIPS) Study

* 18 to 75 years of age
* Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board.

  * Note Pleiomorphic ventricular tachycardia (VT) (multiple MMVT morphologies) is acceptable but polymorphic VT or ventricular fibrillation (VF) is not.

Exclusion Criteria:

* Any history of stroke
* S-T elevation myocardial infarction (MI) or previous cardiac surgery within 60 days prior to enrollment
* Patient is pregnant or nursing
* Patient has New York Heart Association (NYHA) class IV heart failure
* Patient has incessant ventricular tachycardia (VT) necessitating immediate treatment (Patients with Incessant VT have continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥3) hours)
* Patient has VT/VF thought to be from channelopathies
* Limited life expectancy (less than one year) according to Investigator
* Patient has current class IV angina
* Recent coronary artery bypass graft (CABG \< 60 days) or percutaneous coronary intervention (PCI \< 30 days)
* Patient is currently participating in another investigational drug or device study
* Patient is unable or unwilling to cooperate with the study procedures
* Known presence of intracardiac thrombi (i.e., positive Transesophageal Echocardiogram (TEE) for LA or LV clot). TEE is required for history of left atrium (LA) or left ventricle (LV) clot and recommended for history of atrial fibrillation (AF) with CHADS \> 1
* Prosthetic mitral or aortic valve
* Mitral or aortic valvular heart disease requiring immediate surgical intervention
* Major contraindication to anticoagulation therapy or coagulation disorder
* Left Ventricular Ejection Fraction \< 15%
* Patient has had a previous ablation procedure for ventricular tachycardia (VT), excluding remote (\> 3 months) outflow tract tachycardia
* Patient has glomerular filtration rate (GFR) \< 30 mL/min/1.73m2 within the past 3 months
* Patient has peripheral vascular disease that precludes LV access
* Patient has a premature ventricular contraction (PVC) or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD
* Patient has reversible cause of VT
* Use of left ventricular assist device (LVAD) or Tandem Heart devices (Impella and Balloon pumps are acceptable)
* There is a strong clinical reason to believe that, in the opinion of the investigator, the patient only has septal scar that is deep

Primary outcomes:
measure: Number of Subjects Who Experienced an ICD Shock Event.
timeFrame: 12 months
measure: Number of Subjects Who Experienced a Select Serious Adverse Event
timeFrame: 30 days
Secondary outcomes:
measure: Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
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: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: Mid-America Cardiology Associates
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: New York
country: United States
facility: New York University Hospital
state: New York
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital - North
state: New York
city: Charlotte
country: United States
facility: Sanger Clinic
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Heart and Vascular Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: The Woodlands
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Murray
country: United States
facility: Intermountain Heart Rhythm Specialist
state: Utah
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Adelaide
country: Australia
facility: Royale Adelaide Hospital
city: Marseille
country: France
facility: Hopital d'adulte de la Timone
state: Alpes
city: Chambray-lès-Tours
country: France
facility: CHU Trousseau
state: Centre
city: Lyon
country: France
facility: Clinique Protestante
city: Pessac
country: France
facility: Hôpital du Haut Lévêque
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardy
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: Tyne And Wear
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Francis Marchlinski, MD
role: PRINCIPAL_INVESTIGATOR
References: