Comparison of antiarrhythmic medication and catheter ablation in treatment of life threatening ventricular tachyarrhythmias

• Conditions: Ventricular tachyarrhtyhmias in patients with prior myocardial infarction and implantable cardioverter defibrillator; MedDRA version: 17.1Level: LLTClassification code 10007518Term: Cardiac arrhythmiaSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-004954-33-FI
• Lead Sponsor: Central Finland Hospital District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-14
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients 18-80 years of age with prior myocardial infarction and ICD or ICD with biventricular pacing capability (CRT-D) for primary or secondary prevention of sudden cardiac death (SCD), who have had at least two documented episodes of sustained VT or VF and no chronic amiodarone treatment for ventricular tachyarrhythmias, are eligible to participate in the study. The last VT/VF episode should be documented in the foregoing 12 months either ECG or by the device. All patients will give written informed consent for the study before randomization.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Age less than 18 years or more than 80 years
Non-ischemic cardiomyopathy
Ongoing chronic treatment of ventricular tachyarrhytmias with amiodarone
Intolerance/contraindication to all class III antiarrhythmic drugs (i.e., intolerance/contraindication to one class III agents is not excluding the patient if another one can be used)
Contraindication to endocardial catheter ablation (e.g., intracavitary thrombi, contraindication to perioperative anticoagulation)
Previous VT/VF ablation
Open heart surgery within 3 months
Prosthetic heart valve
Planned revascularization (PCI or CABG), surgery for structural heart disease or heart transplantation
Pregnancy or planned pregnancy within the follow-up period
Secondary cause for VT/VF (e.g., acute myocardial infarction)
Patient does not want to participate
Life expectancy less than 12 months

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the study is to evaluate whether catheter based ablation is superior to optimized antiarrhythmic medical therapy in preventing recurrent VT/VF episodes among patients with ischemic heart disease and implantable cardioverter defibrillator (ICD) who are not already using chronic antiarrhythmic medication. ;Secondary Objective: Secondary objectives include evaluation of the impact of the therapies on mortality, hospitalization for cardiac reason, health economics, quality of life and several ICD and arrhythmia related issues.;Primary end point(s): Number of appropriate ICD therapies (defibrillation, cardioversion, antitachycardia pacing) for VT/VF and otherwise documented sustained VT or VF episodes at 12 months.;Timepoint(s) of evaluation of this end point: The primary end point will be evaluated at 12 months.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): All cause mortality<br>Cardiovascular mortality<br>Hospitalization (cause, time to first hospitalization, length of hospitalizations)<br>Ablation/antiarrhythmic medication related side effects including proarrhythmic events<br>Health economics (including planned and unplanned hospitalization and out patients visits, (type, length and number of antiarrhythmic drugs)<br>Quality of life (SF-36, EQ 5D)<br>Patient related outcome<br>Number of appropriate ICD therapies and documented sustained VT or VF episodes at 24 months<br>Number of non-sustained VTs detected by the device<br>Incidence of electric storm<br>Time to first VT/VF episode<br>Time to reablation or change of antiarrhythmic medication (i.e., crossover)<br>Efficacy of ICD therapies<br>Inappropriate ICD therapies<br>Incidence of atrial fibrillation and other sustained supraventricular tachyarrhythmias<br>;Timepoint(s) of evaluation of this end point: Secondary end points will be evaluated at 12 and 24 months.