Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias

NCT ID: NCT02303639

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-06-30

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.

Conditions

Myocardial Infarction; Ventricular Tachyarrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiofrequency catheter ablation

Radiofrequency catheter ablation using open-irrigated ablation catheter and 3D electroanatomical mapping

Group Type: EXPERIMENTAL

Radiofrequency catheter ablation

Intervention Type: PROCEDURE

Catheter ablation with an open-irrigated tip ablation catheter and 3D electroanatomical mapping

Antiarrhythmic drug therapy

Amiodarone (or sotalol) tablet by mouth for the duration of the study

Group Type: ACTIVE_COMPARATOR

Antiarrhythmic drug therapy

Intervention Type: DRUG

Amiodarone (or sotalol) for prevention of VT/VF relapses

Interventions

Radiofrequency catheter ablation

Catheter ablation with an open-irrigated tip ablation catheter and 3D electroanatomical mapping

Intervention Type: PROCEDURE

Antiarrhythmic drug therapy

Amiodarone (or sotalol) for prevention of VT/VF relapses

Intervention Type: DRUG

Other Intervention Names

amiodarone; sotalol; class III antiarrhyhtmic agents

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Central Finland Hospital District

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pekka Raatikainen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Keski-Suomen sairaanhoitopiiri

Locations

Central Finland Central Hospital

Jyväskylä, , Finland

Site Status: RECRUITING

Heart Center Tampere University Hospital

Tampere, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Pekka Raatikainen, MD, PhD

Role: CONTACT

pekka.raatikainen@ksshp.fi

+358503169001

Facility Contacts

Heikki Mäkynen, MD

Role: primary

Other Identifiers

7U/2014

Identifier Type: -

Identifier Source: org_study_id