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INTERVENE: Indian Trial of Endocardial Ventricular Substrate Ablation to Prevent Recurrent VT Events (INTERVENE)

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: NCT02301390
Recruitment Status : Terminated (could not meet enrollment goal)
First Posted : November 25, 2014
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

Brief Summary:

This study to is being conducted in India to determine the role of catheter-based ablation for ventricular tachycardia (VT) in post- heart attack patients who meet established guidelines for implantable cardiodefibrillator (ICD) implantation, but cannot afford it. These patients would be started on chronic Amiodarone therapy, which has been shown to be effective but can often lead to multiple side effects.

Patients will therefore be randomized in an even proportion to either a) the control group, receiving chronic Amiodarone therapy, or the study group, undergoing catheter ablation of VT in addition to chronic Amiodarone therapy.

This trial will serve as a representative model for the developing world.


Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Drug: Amiodarone Device: Catheter Ablation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INTERVENE: Indian Trial of Endocardial Ventricular Substrate Ablation to Prevent Recurrent VT Events
Actual Study Start Date : October 2009
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Active Comparator: Amiodarone only
The control group will receive amiodarone only.
Drug: Amiodarone
Amiodarone is a Class III antiarrhythmic agent.
Other Name: Cordarone

Experimental: Amiodarone + Catheter Ablation
The experimental group will receive amiodarone plus catheter VT ablation.
Drug: Amiodarone
Amiodarone is a Class III antiarrhythmic agent.
Other Name: Cordarone

Device: Catheter Ablation
The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.
Other Name: VT catheter ablation




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: at 24 months ]
    All-cause mortality including Cardiac Arrest and Sustained VT


Secondary Outcome Measures :
  1. Death cases [ Time Frame: up to 24 months ]
    Proportion of subjects that die within 30 days or die by 24 months.

  2. Ventricular arrhythmic events [ Time Frame: at 24 months ]
    Total number of ventricular arrhythmic events, compared between the 2 treatment arms.

  3. Differences in LV ejection fraction [ Time Frame: baseline and 24 months ]
    Differences in LV ejection fraction between paired measurements recorded at baseline and 3 months for each patient will be used to test for significant differences between the two treatment arms.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 and ≤ 85 years of age
  • History of a remote MI (≥1 month)
  • Survival of a ventricular arrhythmic event (VT/VF) that would mandate placement of an implantable cardioverter-defibrillator (ICD) (Patients who experience a ventricular arrhythmic event (VT/VF) while already being treated with Amiodarone (100-200 mg/day) are not excluded from the study. This is permitted provided that the patient had been treated with Amiodarone for at least 2 months prior to experiencing the index VT/VF event. These patients are randomized to either a higher dose of Amiodarone (e.g., 100mg/day -> 200mg/day or 200mg/day -> 400mg/day) or a higher dose of Amiodarone plus catheter ablation.)
  • Patient cannot afford an ICD and thus has been planned for treatment with Amiodarone (or an increased dose of Amiodarone)
  • Ability to understand the requirements of the study
  • Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements

Exclusion Criteria:

  • Patients with NYHA class IV congestive heart failure
  • Prior ablation for a ventricular arrhythmia
  • Presence of an LV thrombus
  • Contraindication to anticoagulation
  • Inability to access the endocardium because of mechanical mitral and aortic valve
  • Life expectance <1 year for any medical condition

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): NCT02301390


Locations
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India
CARE Institute of Medical Science
Ahmedabad, India
CARE Hospital
Hyderabad, India
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry, India
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Biosense Webster, Inc.
Investigators
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Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Calambur Narasimhan, MD CARE Hospital

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Responsible Party: Vivek Reddy, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02301390     History of Changes
Other Study ID Numbers: B14-02-34-05
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
INTERVENE
Ventricular tachycardia
India

Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors