Catheter ablation versus Amiodarone to prevent future shock episodes in patients with a defibrillator and a history of a myocardial infarction.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 238

Inclusion Criteria

1. prior myocardial infarction, at least 3 months ago
2. ICD implantation for any cause except for: Brugada sy, ARVC, HCM, LQTS, SQTS, cathecholaminergic polymorphic VT, other channelopathies
3. ICD shock for VT of VF without a reversible cause
reversible causes (must be checked):
a. Acute myocardial ischemia in the following circumstances:
i. Acute coronary syndrome
ii. Myocardial ischemia as documented by non-invasive myocardial ischemia testing
b. Whenever VT or VF occurs in the setting of antiarrhythmic medication intake (class I or III Vaughn-William) with increased QTc
c. High fever (T>39 degrees Celcius) and signs of infection/sepsis at presentation
d. Lead dislocation on X-ray plus signs of mechanical VT induction
e. Other reversible causes as significant hypoxaemia not caused by cardiac failure or known hyperthyroidism. Judgement whether this will be possible cause of VT/VF will be at discretion of the attending physician
4. Optimal revascularization before ICD implantation performed
5. Written informed consent

Exclusion Criteria

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. unability 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. 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 LV.
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
17. Acute illness or serious active systemic infection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br><br /><br>• Time to reccurrence of documented ICD shock therapy for VT of VF during the<br /><br>follow-up period starting post ablation or after receiving amiodarone. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>• Total number of ICD shocks during follow-up period<br /><br>• Number of VT*s recorded by the ICD<br /><br>• Quality of life (SF-36 score)<br /><br>• Number of hospital readmissions due to a cardiovascular indication<br /><br>• Number of appropriate ICD therapies (including ATP)<br /><br>• Number of appropriate ICD shocks<br /><br>• Number of inappropriate ICD therapies (including ATP)<br /><br>• Number of inappropriate ICD shocks<br /><br>• Severe clinical events (death, syncopes, electrical storm episodes (defined<br /><br>as > 3 VT episodes whithin 24 hours) and cessation of amiodarone due to<br /><br>side-effects)</p><br>