E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to compare the occurrence of sustained VT (longer that 30 seconds or with hemodynamic instability) or next ICD therapy for VT or VF in patients with a history of a myocardial infarction, between patients randomized to substrate based ablation or amiodarone. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints: • Total number of ICD shocks during follow-up period • Number of VT’s recorded by the ICD • Quality of life (SF-36 score) • Number of hospital readmissions due to a cardiovascular indication • Number of appropriate ICD therapies (including ATP) • Number of appropriate ICD shocks • Number of inappropriate ICD therapies (including ATP) • Number of inappropriate ICD shocks • 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)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Not possible to include enough patients |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 1 |