Myocardial infarction, ICD Therapy, sustained VT
Conditions
Interventions
Catheter ablation or medical therapy with Amiodaron. Both interventions are already used in daily practice, but they have never been compared.
Amiodarone dosing: Starting dose:
1. Oral: 1 week 600mg
2. Starting i.v.: 1200mg/24 hour loading dose and afterwards 200mg daily.
Sponsors
Isala Klinieken, Locatie Weezenlanden, Department of Cardiology
Eligibility
Inclusion criteria
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. 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 what can be treated by revascularisation. B. Whenever VT or VF occurs in the setting of antiarrhythmic medication intake (class I or III Vaughn-William) with increased QTc, the patient will not be a candidate for enrolment; C. High fever (T>39 degrees Celsius) and signs of infection/sepsis at presentation will exclude patient from enrolment; D. Lead dislocation on X-ray plus signs of mechanical VT induction will exclude patients from the study; E. Other reversible causes as significant hypoxemia 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 1mg/L the patient will be excluded from the study; 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; 17. Acute illness or serious active systemic infection; 18. Other disease process likely to limit survival to less than 12 months; 19. Lack of availability for follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recurrence of sustained VT (longer that 30 seconds or with hemodynamic instability) or VF with or without documented ICD therapy (shock or ATP) for VT of VF during the follow-up period starting post ablation or after receiving amiodarone. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total number of ICD shocks during follow-up period; 2. Number of VT’s recorded by the ICD; 3. Quality of life (SF-36 score); 4. Number of hospital readmissions due to a cardiovascular indication; 5. Number of appropriate ICD therapies (including ATP); 6. Number of appropriate ICD shocks; 7. Number of inappropriate ICD therapies (including ATP); 8. Number of inappropriate ICD shocks; 9. Severe clinical events (death, syncope’s, electrical storm episodes (defined as > 3 sustained VT episodes within 24 hours) and cessation of amiodarone due to side-effects). | — |
Contacts
Public ContactJ. Klijn
Diagram B.V. Zwolle Dokter Stolteweg 96
Outcome results
None listed