Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. The purpose of this study is to evaluate the optimal management of patients presenting with recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy. The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for recurrent VT.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Sapp
• Collaborators: Abbott Medical Devices; Biosense Webster, Inc.; Canadian Institutes of Health Research (CIHR); St. Jude Medical
• Treatments: Amiodarone; Anti-Arrhythmia Agents

Criteria

Inclusion Criteria:

• Prior Myocardial Infarction

• An implantable defibrillator

• One of the following VT events (within the past 3 months):

• greater than or equal to 3 episodes of symptomatic VT treated with ATP

• greater than or equal to 1 appropriate ICD shock

• greater than or equal to 3 VT episodes within 24 hours

• sustained VT below detection rate of the ICD documented by ECG

• "Failed" first-line antiarrhythmic drug therapy as defined by one of:

• Appropriate ICD therapy or sustained VT occurred while patient was taking amiodarone (stable dose >/= 2 weeks)

• Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (stable dose >/= 2 weeks)

Exclusion Criteria:

• Active ischemia (acute thrombus, dynamic ST elevation on ECG) or another reversible cause of VT (eg. electrolyte abnormalities, drug induced arrhythmia)

• Are known to be ineligible to take amiodarone (eg. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy)

• Are ineligible for ablation (left ventricular thrombus, implanted mechanical aortic and mitral valves)

• Renal Failure (creatinine clearance < 15 ml/min)

• Current NYHA functional class IV heart failure or CCS Functional Class IV angina

• Recent ST elevation myocardial infarction (< 1 month)

• Recent coronary bypass surgery (< 3 mon) or recent PCI (< 1 mon)

• Pregnant

• prior ablation for ventricular tachycardia

• A systemic illness likely to limit survival to < 1 year

• Unable or unwilling to provide informed consent