Ventricular Tachycardia Ablation vs. ENhanced Drug Therapy In Structural Heart Disease

Phase 4

Completed

Conditions: arrhythmia
ventricular tachycardia
ventricular arrhythmia
10007521

Registration Number: NL-OMON36099

Lead Sponsor: The Queen Elizabeth II Health Sciences Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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
11. Have a systemic illness likely to limit survival to < 1 year.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be a composite of death, appropriate ICD shock and VT<br /><br>storm. Shocks and storm during a 1 month post-randomization treatment period<br /><br>will be considered as secondary endpoints. Patients will be followed up for a<br /><br>minimum of 3 years.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints will include the following: all cause mortality,<br /><br>appropriate ICD antitachycardia pacing anytime and after 1 month treatment<br /><br>period, appropriate ICD shocks anytime and after 1 month treatment period, VT<br /><br>storm anytime and after 1 month treatment period, documented sustained VT below<br /><br>detection rate of the ICD any time and after 1 month treatment period,<br /><br>inappropriate shocks anytime and after 1 month treatment period, number of ICD<br /><br>shocks, hospital admission for cardiac causes, procedural complications,<br /><br>amiodarone toxicity or adverse events, effects on ejection fraction,<br /><br>quality of life/anxiety and cost-effectiveness.</p><br>