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

• Conditions: 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.

• Registration Number: EUCTR2009-011790-32-NL
• Lead Sponsor: Isala Klinieken Department Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 310

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified