E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The main objective of this study is to compare the occurrence of next ICD shock therapy for VT or VF in patients with hospital presentation for an ICD shock therapy for VT or VF, with a history of a myocardial infarction, between patients randomized to substrate based ablation or amiodarone. |
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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 |
The main objective of this study is to compare the occurrence of next ICD shock therapy for VT or VF in patients with hospital presentation for an ICD shock therapy for VT or VF, 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 | |
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 sy, ARVC, HCM, LQTS, SQTS, cathecholaminergic polymophic 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 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 Celcius) 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 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
The contribution of electrolyte abnormalities to an episode of unstable VT is notoriously difficult to ascertain, especially if the abnormal electrolyte level is noted after cardiopulmonary resuscitation. In view of this fact, abnormal electrolyte levels will not be used in assessing eligibility for enrollment.
Although volume overload due to heart failure is a possible trigger for VT/VF, it can also be caused by an episode of VT/VF. Therefore, this will not be marked as a reversible cause. If, however, the patient is not successfully treated for the episode of volume overload, he can be excluded from the study. This decision will be at the discretion of the attending physician.
Patients with a cluster of VTs (electrical storm) who require urgent RF ablation are not a suitable candidates for our study. Whether these patients require urgent intervention, will be left at the discretion of the investigator. These patients will be registered.
4. Optimal revascularization before ICD implantation performed
5. Written informed consent Patients who meet the inclusion and exclusion criteria and sign the informed consent will be considered enrolled in the study. No patient will be enrolled without an informed consent document signed by the patient. Informed consent forms have to be in compliance with the latest Declaration of Helsinki.
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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. unability 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to reccurrence of documented ICD shock therapy 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) | Yes |
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.8.5.1 | Number of sites anticipated in the EEA | 0 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 13 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 15 |