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

NCT02301390 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-01-27

Study results available
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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

Interventions

DRUG

Amiodarone

Amiodarone is a Class III antiarrhythmic agent.

DEVICE

Catheter Ablation

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

Sponsors & Collaborators

Principal Investigators

  • Vivek Reddy, MD · Icahn School of Medicine at Mount Sinai

  • Calambur Narasimhan, MD · CARE Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2016-06-30
Completion
2016-09-30

Countries

  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02301390 on ClinicalTrials.gov