Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT)

Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132

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.

Study Overview

• Status: Terminated
• Conditions: Monomorphic Ventricular Tachycardia
• Intervention / Treatment: Device: Cardiac catheter ablation with ICD/CRT-D

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Royale Adelaide Hospital
• France
  • Lyon, France, 69300
    • Clinique Protestante
  • Pessac, France, 33604
    • Hôpital du Haut Lévêque
  • Alpes
    • Marseille, Alpes, France, 13005
      • Hopital d'adulte de la Timone
  • Centre
    • Chambray-lès-Tours, Centre, France, 37170
      • CHU Trousseau
• Italy
  • Lombardy
    • Milano, Lombardy, Italy, 20132
      • Ospedale San Raffaele
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • Tyne And Wear
    • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
      • Freeman Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90033
      • USC University Hospital
    • San Diego, California, United States, 92103
      • University of California at San Diego (UCSD) Medical Center
    • San Francisco, California, United States, 94143
      • University of California at San Francisco
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Mid-America Cardiology Associates
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital St. Louis
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine - Barnes Jewish Hospital
  • New York
    • New York, New York, United States, 10016
      • New York University Hospital
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
    • New York, New York, United States, 10029
      • Mt. Sinai Hospital
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital - North
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Sanger Clinic
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Of Cleveland
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19118
      • Hospital of the University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Heart and Vascular Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
    • The Woodlands, Texas, United States, 77380
      • Memorial Hermann Hospital
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Heart Rhythm Specialist
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Drug with ICD/CRT-D; Implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) with routine drug therapy
Active Comparator: Cardiac catheter ablation with ICD/CRT-D; Cardiac catheter ablation with ICD/CRT-D with routine drug therapy	Device: Cardiac catheter ablation with ICD/CRT-D; Cardiac ablation catheter system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Who Experienced an ICD Shock Event.	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	12 months
Number of Subjects Who Experienced a Select Serious Adverse Event	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit	Number of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up.	12 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Francis Marchlinski, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): July 25, 2016
• Study Completion (Actual): July 25, 2016

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (Estimate): May 5, 2014

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Catheter Ablation; Ischemic; Monomorphic Ventricular Tachycardia; Non-ischemic
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: SJM-CIP-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes