Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias
Information source: Central Finland Hospital District
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Infarction; Ventricular Tachyarrhythmia
Intervention: Radiofrequency catheter ablation (Procedure); Antiarrhythmic drug therapy (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Central Finland Hospital District Official(s) and/or principal investigator(s): Pekka Raatikainen, MD PhD, Principal Investigator, Affiliation: Keski-Suomen sairaanhoitopiiri
Overall contact: Pekka Raatikainen, MD, PhD, Phone: +358503169001, Email: pekka.raatikainen@ksshp.fi
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.
Clinical Details
Official title: Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes
Secondary outcome: All cause mortalityCardiovascular mortality Time to first hospitalization and number of hospital days Comparative cost-effectiveness of the therapies Quality of life measured By SF-36 and EQ5D questionnaires Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires Number of appropriate ICD therapies and sustained VT/VF episodes Number of non-sustained VT episodes Number of electrical storm episodes Time to first VT/VF Time to reablation Number of inappropriate ICD therapies Number of atrial fibrillation and other supraventricular arrhythmia episodes
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 patients with prior myocardial infarction and implantable cardioverter
defibrillator (ICD). The patients have not been using using chronic antiarrhythmic
medication. Primary end point is number of ICD therapies (defibrillations, cardioversions
and antitachycardia pacing) and otherwise documented sustained ventricular tachycardia
(duration more than 30 s or hemodynamically unstable ) or ventricular fibrillation episodes
during 12 months follow-up period. Secondary end points include mortality, hospitalization
for cardiac reason, health economics, quality of life and several ICD and arrhythmia related
issues. Total length of the follow-up is at least two years.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Pekka Raatikainen, MD, PhD, Phone: +358503169001, Email: pekka.raatikainen@ksshp.fi
Central Finland Central Hospital, Jyväskylä, Finland
Additional Information
Starting date: December 2014
Last updated: November 28, 2014
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