Status:
COMPLETED
Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy
Lead Sponsor:
John Sapp
Collaborating Sponsors:
Abbott Medical Devices
Biosense Webster, Inc.
Conditions:
Recurrent Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ev...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00905853
Start Date
May 1 2009
End Date
December 1 2015
Last Update
July 11 2016
Active Locations (1)
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1
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7