Catheter ablation versus Amiodarone to pRevent Future ventricular tachycardia Episodes in patients with a defibrillator and a history of a myocardial infarction - CARFE 2

Conditions: The primary purpose of this randomized study is the assessment of recurrences of sustained VT and ICD therapy for VT or VF after appropriate ICD therapy (ATP or shock) in patients with a history of a myocardial infarction undergoing substrate based ablation compared to patients treated with amiodarone alone. Thus the primary purpose is reduction of time to next appropriate ICD therapy or sustained VT.

Registration Number: EUCTR2011-001141-32-NL

Lead Sponsor: Isala klinieken department Cardiology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.prior myocardial infarction, at least 3 months ago

2.ICD implantation for any cause except for: Brugada syndrome, ARVC, HCM, LQTS, SQTS, cathecholaminergic polymorphic VT, other channelopathies

3.ICD therapy (shock or ATP) for VT or VF without a reversible cause
4.Optimal revascularization before ICD implantation performed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 ½T prior to randomization
5.Protruding LV thrombus or cardiac tumor on pre-ablation echocardiogram
6.Acute myocardial infarction within the preceding 3 months
7.non-reversible Class IV NYHA heart failure
8.Valvular heart disease or mechanical heart valve precluding access to the left ventricle.
9.Unstable coronary artery syndrome or active myocardial infarction
10.Cardiac surgery within the past 2 months
11.mechanical mitral or tricuspid valve prothesis
12.Serum creatinine > 220 mmol/L (2.5 mg/dL)
13.Thrombocytopenia or coagulopathy
14.Contraindication to anticoagulation
15.stroke within past 30 days
16.Pregnancy