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To determine the role of catheter based VT ablation in the prevention of recurrent VT in post-MI patients who survive a life-threatening VT/VF event but cannot afford an implantable defibrillator. Patients will be randomized to either Amiodarone or Amiodarone plus catheter ablation.

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/07/002827
Enrollment
132
Registered
2012-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Ventricular Tachycardia

Interventions

Intervention1: Catheter ablation and amiodarone: Interventional arm would be compared to standard amiodarone drug therapy,duration of amiodarone is from randomization to completion of study. Control I

Sponsors

CARE Hospital
Lead Sponsor
Biosense Webster
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: more than 18 and less than 85 years of age History of a remote MI of more than 1 month Survival of a ventricular arrhythmic event VT or VF that would mandate placement of an implantable cardioverter-defibrillator Patient cannot afford an ICD and thus has been planned for treatment with Amiodarone Ability to understand the requirements of the study Willingness to adhere to study restrictions and comply with all postprocedural follow-up requirements

Exclusion criteria

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 expectancy of less than 1 year for any medical condition

Design outcomes

Primary

MeasureTime frame
All-cause mortality and Cardiac Arrest and Sustained VTTimepoint: 24 months

Secondary

MeasureTime frame
Proportion of subjects that die within 30 days or by the end of the study Total number of ventricular arrhythmic events, compared between the 2 treatment arms. 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. Quality of life. Timepoint: 30days 24months 3 months

Countries

India

Contacts

Public ContactDr Narasimhan

CARE Hospital

dr_csridevi@yahoo.com040301418424

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026