Clinical trial NCT02303639: Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias
Official title: Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myocardial Infarction
Ventricular Tachyarrhythmia
Keywords: implantable cardioverter defibrillator
antiarrhythmic medication
catheter ablation
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2014-12-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 heart disease and implantable cardioverter defibrillator.

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 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

Primary outcomes:
measure: Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes
timeFrame: 12 months
Secondary outcomes:
measure: All cause mortality
timeFrame: 12 and 24 months
measure: Cardiovascular mortality
timeFrame: 12 and 24 months
measure: Time to first hospitalization and number of hospital days
timeFrame: 12 and 24 months
measure: Comparative cost-effectiveness of the therapies
timeFrame: 12 and 24 months
measure: Quality of life measured By SF-36 and EQ5D questionnaires
timeFrame: 12 and 24 months
measure: Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires
timeFrame: 12 and 24 months
measure: Number of appropriate ICD therapies and sustained VT/VF episodes
timeFrame: 24 months
measure: Number of non-sustained VT episodes
timeFrame: 12 and 24 months
measure: Number of electrical storm episodes
timeFrame: 12 and 24 months
measure: Time to first VT/VF
timeFrame: up to 24 months
measure: Time to reablation
timeFrame: up to 24 months
measure: Number of inappropriate ICD therapies
timeFrame: up to 24 months
measure: Number of atrial fibrillation and other supraventricular arrhythmia episodes
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
city: Tampere
country: Finland
facility: Heart Center Tampere University Hospital
Study officials:
affiliation: Keski-Suomen sairaanhoitopiiri
name: Pekka Raatikainen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: