Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy
- Conditions
- Recurrent Ventricular Tachycardia
- Interventions
- Procedure: Catheter AblationDrug: Escalated Antiarrhythmic Therapy
- Registration Number
- NCT00905853
- Lead Sponsor
- John Sapp
- Brief 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.
- Detailed Description
This is a multicentre, parallel group, two arm, unblinded, randomized clinical trial to compare two management strategies for patients with ischemic heart disease and recurrent ICD therapy despite at least one antiarrhythmic drug. The primary endpoint will be a composite of appropriate ICD shocks or death.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ventricular Tachycardia Ablation Catheter Ablation Catheter ablation for Ventricular tachycardia will be performed within 14 days of randomization. Escalated Antiarrhythmic Drug Therapy Escalated Antiarrhythmic Therapy Patients are prescribed a loading dose of amiodarone or the addition of mexiletine to their current anti-arrhythmic medication which is stratified by the dose and type of antiarrhymic medication at the time of the index arrhythmic event.
- Primary Outcome Measures
Name Time Method Appropriate ICD shocks,VT storm and death 3 years
- Secondary Outcome Measures
Name Time Method All cause mortality 3 years Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period 3 years appropriate ICD shocks anytime and after 1 month treatment period 3 years Procedural complications, amiodarone toxicity or adverse events 3 years Inappropriate shocks anytime and after 1 month treatment period 3 years Number of ICD shocks 3 years Hospital admission for cardiac causes 3 years VT storm anytime and after 1 month treatment period 3 years Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period 3 years
Trial Locations
- Locations (1)
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada