Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study evaluates whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses in patients with ischemic heart disease and implantable cardioverter defibrillator.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Finland Hospital District
• Collaborator: Biosense Webster, Inc.
• Treatments: Amiodarone; Anti-Arrhythmia Agents; Sotalol

Criteria

Inclusion Criteria:

• Patients 18-80 years of age with prior myocardial infarction and ICD (single chamber, dual chamber 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

Exclusion Criteria:

• Age less than 18 years or more than 80 years

• Non-ischemic cardiomyopathy

• Ongoing chronic treatment of ventricular tachyarrhythmias 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