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

NCT02301390 | Terminated Results DMC

• 1 other identifier: B14-02-34-05
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

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.

Conditions

Ventricular Tachycardia

Keywords

INTERVENE; Ventricular tachycardia; India

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Were Free From All-cause Mortality, Sustained VT or Cardiac Arrest

  Number of participants who had no occurrences of all-cause mortality, sustained ventricular tachycardia (VT) and cardiac arrest at 24 months

  at 24 months

Secondary Outcomes (3)

• Number of Participant Who Died

  up to 24 months

• Ventricular Arrhythmic Events

  at 24 months

• Change in LV Ejection Fraction

  baseline and 24 months

Study Arms (2)

Amiodarone only

ACTIVE COMPARATOR

The control group will receive amiodarone only.

Drug: Amiodarone

Amiodarone + Catheter Ablation

EXPERIMENTAL

The experimental group will receive amiodarone plus catheter VT ablation.

Drug: Amiodarone; Device: Catheter Ablation

Interventions

Amiodarone DRUG

Amiodarone is a Class III antiarrhythmic agent.

Also known as: Cordarone

Amiodarone + Catheter Ablation; Amiodarone only

Catheter Ablation DEVICE

The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.

Also known as: VT catheter ablation

Amiodarone + Catheter Ablation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Biosense Webster, Inc.: collaborator

Study Sites (3)

CARE Institute of Medical Science

Ahmedabad, India

Location

CARE Hospital

Hyderabad, India

Location

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

Puducherry, India

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Amiodarone; Catheter Ablation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Betsy Ellsworth, Research Program Director
• Organization: Icahn School of Medicine at Mount Sinai

betsy.ellsworth@mountsinai.org

212-824-8902

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Calambur Narasimhan, MD

  CARE Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: October 1, 2009
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3)