Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias

NCT02303639 | Unknown Phase 4 DMC

• 1 other identifier: 7U/2014
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Myocardial Infarction; Ventricular Tachyarrhythmia

Keywords

implantable cardioverter defibrillator; antiarrhythmic medication; catheter ablation

Outcome Measures

Primary Outcomes (1)

• Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes

  • Number of appropriate ICD therapies (defibrillation, cardioversion, antitachycardia pacing) for VT/VF and otherwise documented sustained VT or VF episodes at 12 months

  12 months

Secondary Outcomes (13)

• All cause mortality

  12 and 24 months

• Cardiovascular mortality

  12 and 24 months

• Time to first hospitalization and number of hospital days

  12 and 24 months

• Comparative cost-effectiveness of the therapies

  12 and 24 months

• Quality of life measured By SF-36 and EQ5D questionnaires

  12 and 24 months

Study Arms (2)

Radiofrequency catheter ablation

EXPERIMENTAL

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

Procedure: Radiofrequency catheter ablation

Antiarrhythmic drug therapy

ACTIVE COMPARATOR

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

Drug: Antiarrhythmic drug therapy

Interventions

Radiofrequency catheter ablation PROCEDURE

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

Radiofrequency catheter ablation

Antiarrhythmic drug therapy DRUG

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

Also known as: amiodarone, sotalol, class III antiarrhyhtmic agents

Antiarrhythmic drug therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Finland Hospital District: lead
• Biosense Webster, Inc.: collaborator

Study Sites (2)

Central Finland Central Hospital

Jyväskylä, Finland

RECRUITING

Heart Center Tampere University Hospital

Tampere, Finland

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Tachycardia, Ventricular

Interventions

Catheter Ablation; Amiodarone; Sotalol

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Pekka Raatikainen, MD PhD

  Keski-Suomen sairaanhoitopiiri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pekka Raatikainen, MD, PhD

CONTACT

+358503169001; pekka.raatikainen@ksshp.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: December 1, 2014
• Study Start: April 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

FI (2)