Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia
- Conditions
- Monomorphic Ventricular Tachycardia
- Interventions
- Device: Cardiac catheter ablation with ICD/CRT-D
- Registration Number
- NCT02130765
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 64
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cardiac catheter ablation with ICD/CRT-D Cardiac catheter ablation with ICD/CRT-D Cardiac catheter ablation with ICD/CRT-D with routine drug therapy
- Primary Outcome Measures
Name Time Method Number of Subjects Who Experienced an ICD Shock Event. 12 months Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up
Number of Subjects Who Experienced a Select Serious Adverse Event 30 days Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List.
- Secondary Outcome Measures
Name Time Method Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit 12 months Number of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up.
Trial Locations
- Locations (38)
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Johns Hopkins University Hospital
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Memorial Hermann Hospital
🇺🇸The Woodlands, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Mid-America Cardiology Associates
🇺🇸Kansas City, Kansas, United States
Vanderbilt Heart and Vascular Institute
🇺🇸Nashville, Tennessee, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
USC University Hospital
🇺🇸Los Angeles, California, United States
University of California at San Diego (UCSD) Medical Center
🇺🇸San Diego, California, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Hôpital du Haut Lévêque
🇫🇷Pessac, France
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Washington University School of Medicine - Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
New York University Hospital
🇺🇸New York, New York, United States
Staten Island University Hospital - North
🇺🇸Staten Island, New York, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Mt. Sinai Hospital
🇺🇸New York, New York, United States
Sanger Clinic
🇺🇸Charlotte, North Carolina, United States
Intermountain Heart Rhythm Specialist
🇺🇸Murray, Utah, United States
Clinique Protestante
🇫🇷Lyon, France
Hopital d'adulte de la Timone
🇫🇷Marseille, Alpes, France
Royale Adelaide Hospital
🇦🇺Adelaide, Australia
CHU Trousseau
🇫🇷Chambray-lès-Tours, Centre, France
Ospedale San Raffaele
🇮🇹Milano, Lombardy, Italy
Freeman Hospital
🇬🇧Newcastle upon Tyne, Tyne And Wear, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom