Status:
TERMINATED
INTERVENE: Indian Trial of Endocardial Ventricular Substrate Ablation to Prevent Recurrent VT Events
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Biosense Webster, Inc.
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
18-85 years
Phase:
NA
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 implantab...
Detailed Description
Sudden cardiac death (SCD) accounts for approximately 50% of all cardiac death, representing an estimated annual incidence ranging from 250,000 to 350,000 cases in the United States. The pathophysiolo...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02301390
Start Date
October 1 2009
End Date
September 1 2016
Last Update
January 27 2020
Active Locations (3)
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1
CARE Institute of Medical Science
Ahmedabad, India
2
CARE Hospital
Hyderabad, India
3
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry, India