Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias

Myocardial Infarction Clinical Trial

— MANTRA-VT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02303639
• Other study ID #: 7U/2014
• Status: Recruiting
• Phase: Phase 4
• First received: November 21, 2014
• Last updated: August 31, 2016
• Start date: April 2015
• Est. completion date: June 2018

Study information

• Verified date: August 2016
• Source: Central Finland Hospital District
• Contact: Pekka Raatikainen, MD, PhD
• Phone: +358503169001
• Email: pekka.raatikainen[@]ksshp.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachyarrhythmia

Intervention

Procedure:
• Radiofrequency catheter ablation
Catheter ablation with an open-irrigated tip ablation catheter and 3D electroanatomical mapping

Drug:
• Antiarrhythmic drug therapy
Amiodarone (or sotalol) for prevention of VT/VF relapses

Locations

Country	Name	City	State
Finland	Central Finland Central Hospital	Jyväskylä
Finland	Heart Center Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Central Finland Hospital District	Biosense Webster, Inc.

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	All cause mortality		12 and 24 months	Yes
Secondary	Cardiovascular mortality		12 and 24 months	Yes
Secondary	Time to first hospitalization and number of hospital days		12 and 24 months	Yes
Secondary	Comparative cost-effectiveness of the therapies		12 and 24 months	No
Secondary	Quality of life measured By SF-36 and EQ5D questionnaires		12 and 24 months	No
Secondary	Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires		12 and 24 months	No
Secondary	Number of appropriate ICD therapies and sustained VT/VF episodes		24 months	Yes
Secondary	Number of non-sustained VT episodes		12 and 24 months	Yes
Secondary	Number of electrical storm episodes		12 and 24 months	Yes
Secondary	Time to first VT/VF		up to 24 months	Yes
Secondary	Time to reablation		up to 24 months	Yes
Secondary	Number of inappropriate ICD therapies		up to 24 months	Yes
Secondary	Number of atrial fibrillation and other supraventricular arrhythmia episodes		up to 24 months	Yes