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

Primary Purpose

Myocardial Infarction, Ventricular Tachyarrhythmia

Status

Unknown status

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

Radiofrequency catheter ablation

Antiarrhythmic drug therapy

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring implantable cardioverter defibrillator, antiarrhythmic medication, catheter ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Central Finland Central HospitalRecruiting
Heart Center Tampere University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radiofrequency catheter ablation

Antiarrhythmic drug therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All cause mortality

Cardiovascular mortality

Time to first hospitalization and number of hospital days

Comparative cost-effectiveness of the therapies

Quality of life measured By SF-36 and EQ5D questionnaires

Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires

Number of appropriate ICD therapies and sustained VT/VF episodes

Number of non-sustained VT episodes

Number of electrical storm episodes

Time to first VT/VF

Time to reablation

Number of inappropriate ICD therapies

Number of atrial fibrillation and other supraventricular arrhythmia episodes

Full Information

NCT ID

NCT02303639

First Posted

November 21, 2014

Last Updated

August 31, 2016

Sponsor

Central Finland Hospital District

Collaborators

Biosense Webster, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02303639

Brief Title

Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias

Acronym

MANTRA-VT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Finland Hospital District

Collaborators

Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, Ventricular Tachyarrhythmia

Keywords

implantable cardioverter defibrillator, antiarrhythmic medication, catheter ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiofrequency catheter ablation

Arm Type

Experimental

Arm Description

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

Arm Title

Antiarrhythmic drug therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Radiofrequency catheter ablation

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Antiarrhythmic drug therapy

Other Intervention Name(s)

amiodarone, sotalol, class III antiarrhyhtmic agents

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

All cause mortality

Time Frame

12 and 24 months

Title

Cardiovascular mortality

Time Frame

12 and 24 months

Title

Time to first hospitalization and number of hospital days

Time Frame

12 and 24 months

Title

Comparative cost-effectiveness of the therapies

Time Frame

12 and 24 months

Title

Quality of life measured By SF-36 and EQ5D questionnaires

Time Frame

12 and 24 months

Title

Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires

Time Frame

12 and 24 months

Title

Number of appropriate ICD therapies and sustained VT/VF episodes

Time Frame

24 months

Title

Number of non-sustained VT episodes

Time Frame

12 and 24 months

Title

Number of electrical storm episodes

Time Frame

12 and 24 months

Title

Time to first VT/VF

Time Frame

up to 24 months

Title

Time to reablation

Time Frame

up to 24 months

Title

Number of inappropriate ICD therapies

Time Frame

up to 24 months

Title

Number of atrial fibrillation and other supraventricular arrhythmia episodes

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pekka Raatikainen, MD, PhD

Phone

+358503169001

pekka.raatikainen@ksshp.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pekka Raatikainen, MD PhD

Organizational Affiliation

Keski-Suomen sairaanhoitopiiri

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Finland Central Hospital

City

Jyväskylä

Country

Finland

Individual Site Status

Recruiting

Facility Name

Heart Center Tampere University Hospital

City

Tampere

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heikki Mäkynen, MD

12. IPD Sharing Statement

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Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias

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