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.
Conditions
Interventions
Trade Name: Cordarone
Pharmaceutical Form: Tablet
Sponsors
Isala Klinieken Department Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria: 1. Age 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 |
|---|---|
| Main Objective: 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.;Secondary Objective: ;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. | — |
Countries
Netherlands
Outcome results
None listed