Catheter ablation versus Amiodarone to pRevent Future ventricular tachycardia Episodes in patients with a defibrillator and a history of a myocardial infarctio

Phase 4

Completed

Conditions: 10043413
Heart rythm disturbances /ICD shocks
10007521

Registration Number: NL-OMON35926

Lead Sponsor: Diagram B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 116

Inclusion Criteria

1. prior myocardial infarction, at least 3 months ago
2. ICD implantation
3. ICD shock or ATP for VT or VF without a reversible cause reversible causes
4. Optimal revascularization before ICD implantation performed

Exclusion Criteria

1. Age < 18 years
2. use of amiodarone more than 7 days before randomization within the period of 3 months before randomization
3. Inability to use amiodarone due to past side effects
4. Class I antiarrythmic drugs not stopped <= 5 times *T prior to randomization
5. Protruding LV thrombus or cardiac tumor on pre-ablation echocardiogram
6. non-reversible Class IV NYHA heart failure

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the assessment of recurrences of sustained VT (longer that 30 seconds or with<br /><br>hemodynamic instability) or VF with or without ICD therapy for VT or VF after<br /><br>appropriate ICD therapy (ATP or shock) in patients with a history of a<br /><br>myocardial infarction undergoing substrate based ablation compared to patients<br /><br>treated with amiodarone alone. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Time to recurrence of sustained VT (longer that 30 seconds or with hemodynamic<br /><br>instability) or VF with or without documented ICD therapy (shock or ATP) for<br /><br>VT of VF during the follow-up period starting post ablation or after receiving<br /><br>amiodarone. </p><br>