Catheter ablation versus Amiodarone to pRevent Future ventricular tachycardia Episodes in patients with a defibrillator and a history of a myocardial infarction.

Suspended

• Conditions: Myocardial infarction, ICD Therapy, sustained VT

• Registration Number: NL-OMON21395
• Lead Sponsor: Isala Klinieken, Locatie Weezenlanden, Department of Cardiology

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 116

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;

Exclusion Criteria

1. Age < 18 years;

2. Use of amiodarone more than 7 days before randomization within the period of 3 months before randomization. If a patient used amiodarone in preceding 3 months, the plasma levels of amiodarone and desethylamiodarone will be determined. If both levels are > 1mg/L the patient will be excluded from the study;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Total number of ICD shocks during follow-up period;<br /><br>2. Number of VT’s recorded by the ICD;<br /><br>3. Quality of life (SF-36 score);<br /><br>4. Number of hospital readmissions due to a cardiovascular indication;<br /><br>5. Number of appropriate ICD therapies (including ATP);<br /><br>6. Number of appropriate ICD shocks;<br /><br>7. Number of inappropriate ICD therapies (including ATP);<br /><br>8. Number of inappropriate ICD shocks;<br /><br>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).