NL-OMON36099
Completed
Phase 4
Ventricular Tachycardia Ablation vs. ENhanced Drug Therapy In Structural Heart Disease - VANISH study
The Queen Elizabeth II Health Sciences Centre0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- arrhythmia
- Sponsor
- The Queen Elizabeth II Health Sciences Centre
- Enrollment
- 50
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non\-ischemic cause)73
- •2\. An implantable defibrillator
- •3\. One of the following VT events (within last 3 months):
- •A: \*3 episodes of symptomatic VT treated with antitachycardia pacing (ATP),
- •B: \*1 appropriate ICD shocks,
- •C: \*3 VT episodes within 24 hr
- •D: sustained VT below detection rate of the ICD documented by ECG/cardiac monitor
- •4\. \*Failed\* first\-line antiarrhythmic drug therapy (Class 1 or 3\) as defined by one of:
- •A: Appropriate ICD therapy or sustained VT occurred while the patient was taking amiodarone (patient on a stable dose for \* 2 weeks)
- •B: Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (patient on a stable dose for \* 2 weeks)
Exclusion Criteria
- •1\. Are unable or unwilling to provide informed consent.
- •2\. Have an acute coronary syndrome (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. electrolyte abnormalities, drug\-induced arrhythmia)
- •3\. Are known to be ineligible to take amiodarone, e.g. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy.
- •4\. Are ineligible for ablation (known to have protruding left ventricular thrombus, or have implanted mechanical aortic and mitral valves)
- •5\. Are in renal failure (Creatinine clearance \<15 ml/min)
- •6\. Have current NYHA Functional class IV heart failure or CCS Functional class IV angina
- •7\. Had recent ST elevation myocardial infarction (\< 1 month)
- •8\. Had recent coronary bypass surgery (\< 3 months) or percutaneous coronary intervention (\<1 month)
- •9\. Are pregnant
- •10\. Have had prior ablation for ventricular tachycardia
Outcomes
Primary Outcomes
Not specified
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