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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02130765
Recruitment Status : Terminated (Terminated due to low enrollment rate.)
First Posted : May 5, 2014
Results First Posted : October 15, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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.

Condition or disease Intervention/treatment Phase
Monomorphic Ventricular Tachycardia Device: Cardiac catheter ablation with ICD/CRT-D Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132
Study Start Date : November 2014
Actual Primary Completion Date : July 25, 2016
Actual Study Completion Date : July 25, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects Who Experienced an ICD Shock Event. [ Time Frame: 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

  2. Number of Subjects Who Experienced a Select Serious Adverse Event [ Time Frame: 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 :
  1. Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit [ Time Frame: 12 months ]
    Number of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130765


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Francis Marchlinski, MD University of Pennsylvania
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02130765    
Other Study ID Numbers: SJM-CIP-0005
First Posted: May 5, 2014    Key Record Dates
Results First Posted: October 15, 2018
Last Update Posted: February 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Abbott Medical Devices:
Monomorphic Ventricular Tachycardia
Ischemic
Non-ischemic
Catheter Ablation
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes