Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2016
• Main ID: NCT02303639
• Date of registration: 21/11/2014
• Prospective Registration: Yes
• Primary sponsor: Central Finland Hospital District
• Public title: Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias MANTRA-VT
• Scientific title: Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study.
• Date of first enrolment: April 2015
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02303639
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Finland

Contacts

• Name: Heikki Mäkynen, MD

• Name: Pekka Raatikainen, MD PhD
• Affiliation: Keski-Suomen sairaanhoitopiiri

• Name: Pekka Raatikainen, MD, PhD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Myocardial Infarction

Ventricular Tachyarrhythmia

Intervention(s)

Drug: Antiarrhythmic drug therapy

Procedure: Radiofrequency catheter ablation

Primary Outcome(s)

Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes [Time Frame: 12 months]

Secondary Outcome(s)

Number of non-sustained VT episodes [Time Frame: 12 and 24 months]

Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires [Time Frame: 12 and 24 months]

Time to first hospitalization and number of hospital days [Time Frame: 12 and 24 months]

Time to first VT/VF [Time Frame: up to 24 months]

Number of inappropriate ICD therapies [Time Frame: up to 24 months]

Time to reablation [Time Frame: up to 24 months]

Number of atrial fibrillation and other supraventricular arrhythmia episodes [Time Frame: up to 24 months]

Comparative cost-effectiveness of the therapies [Time Frame: 12 and 24 months]

Quality of life measured By SF-36 and EQ5D questionnaires [Time Frame: 12 and 24 months]

Cardiovascular mortality [Time Frame: 12 and 24 months]

Number of appropriate ICD therapies and sustained VT/VF episodes [Time Frame: 24 months]

All cause mortality [Time Frame: 12 and 24 months]

Number of electrical storm episodes [Time Frame: 12 and 24 months]

Secondary ID(s)

7U/2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biosense Webster, Inc.