Status:
UNKNOWN
Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias
Lead Sponsor:
Central Finland Hospital District
Collaborating Sponsors:
Biosense Webster, Inc.
Conditions:
Myocardial Infarction
Ventricular Tachyarrhythmia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
The study is designed to evaluate whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses among patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02303639
Start Date
April 1 2015
End Date
June 1 2018
Last Update
September 1 2016
Active Locations (2)
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1
Central Finland Central Hospital
Jyväskylä, Finland
2
Heart Center Tampere University Hospital
Tampere, Finland