Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias (MANTRA-VT)

Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study.

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.

Study Overview

• Status: Unknown
• Conditions: Myocardial Infarction; Ventricular Tachyarrhythmia
• Intervention / Treatment: Procedure: Radiofrequency catheter ablation; Drug: Antiarrhythmic drug therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pekka Raatikainen, MD, PhD; Phone Number: +358503169001; Email: pekka.raatikainen@ksshp.fi

Study Locations

• Finland
  • Jyväskylä, Finland
    • Recruiting
    • Central Finland Central Hospital
  • Tampere, Finland
    • Recruiting
    • Heart Center Tampere University Hospital
    • Contact: Heikki Mäkynen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency catheter ablation; Radiofrequency catheter ablation using open-irrigated ablation catheter and 3D electroanatomical mapping	Procedure: Radiofrequency catheter ablation; Catheter ablation with an open-irrigated tip ablation catheter and 3D electroanatomical mapping
Active Comparator: Antiarrhythmic drug therapy; Amiodarone (or sotalol) tablet by mouth for the duration of the study	Drug: Antiarrhythmic drug therapy; Amiodarone (or sotalol) for prevention of VT/VF relapses; Other Names: amiodarone; sotalol; class III antiarrhyhtmic agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires	12 and 24 months
Number of appropriate ICD therapies and sustained VT/VF episodes	24 months
Number of non-sustained VT episodes	12 and 24 months
Number of electrical storm episodes	12 and 24 months
Time to first VT/VF	up to 24 months
Time to reablation	up to 24 months
Number of inappropriate ICD therapies	up to 24 months
Number of atrial fibrillation and other supraventricular arrhythmia episodes	up to 24 months

Collaborators and Investigators

• Sponsor: Central Finland Hospital District
• Collaborators: Biosense Webster, Inc.
• Investigators: Principal Investigator: Pekka Raatikainen, MD PhD, Keski-Suomen sairaanhoitopiiri

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: November 28, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Estimate): September 1, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: catheter ablation; implantable cardioverter defibrillator; antiarrhythmic medication
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Myocardial Infarction; Infarction; Tachycardia; Tachycardia, Ventricular; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Sympatholytics; Potassium Channel Blockers; Amiodarone; Sotalol; Anti-Arrhythmia Agents
• Other Study ID Numbers: 7U/2014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No