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

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ClinicalTrials.gov Identifier: NCT02303639
Recruitment Status : Unknown
Verified August 2016 by Central Finland Hospital District.
Recruitment status was:  Recruiting
First Posted : December 1, 2014
Last Update Posted : September 1, 2016
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Central Finland Hospital District

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Ventricular Tachyarrhythmia Procedure: Radiofrequency catheter ablation Drug: Antiarrhythmic drug therapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study.
Study Start Date : April 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018


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




Primary Outcome Measures :
  1. Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes [ Time Frame: 12 months ]
    • 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 :
  1. All cause mortality [ Time Frame: 12 and 24 months ]
  2. Cardiovascular mortality [ Time Frame: 12 and 24 months ]
  3. Time to first hospitalization and number of hospital days [ Time Frame: 12 and 24 months ]
  4. Comparative cost-effectiveness of the therapies [ Time Frame: 12 and 24 months ]
  5. Quality of life measured By SF-36 and EQ5D questionnaires [ Time Frame: 12 and 24 months ]
  6. Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires [ Time Frame: 12 and 24 months ]
  7. Number of appropriate ICD therapies and sustained VT/VF episodes [ Time Frame: 24 months ]
  8. Number of non-sustained VT episodes [ Time Frame: 12 and 24 months ]
  9. Number of electrical storm episodes [ Time Frame: 12 and 24 months ]
  10. Time to first VT/VF [ Time Frame: up to 24 months ]
  11. Time to reablation [ Time Frame: up to 24 months ]
  12. Number of inappropriate ICD therapies [ Time Frame: up to 24 months ]
  13. Number of atrial fibrillation and other supraventricular arrhythmia episodes [ Time Frame: up to 24 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303639


Contacts
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Contact: Pekka Raatikainen, MD, PhD +358503169001 pekka.raatikainen@ksshp.fi

Locations
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Finland
Central Finland Central Hospital Recruiting
Jyväskylä, Finland
Heart Center Tampere University Hospital Recruiting
Tampere, Finland
Contact: Heikki Mäkynen, MD         
Sponsors and Collaborators
Central Finland Hospital District
Biosense Webster, Inc.
Investigators
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Principal Investigator: Pekka Raatikainen, MD PhD Keski-Suomen sairaanhoitopiiri

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Responsible Party: Central Finland Hospital District
ClinicalTrials.gov Identifier: NCT02303639     History of Changes
Other Study ID Numbers: 7U/2014
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016

Keywords provided by Central Finland Hospital District:
implantable cardioverter defibrillator
antiarrhythmic medication
catheter ablation

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Tachycardia
Tachycardia, Ventricular
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Amiodarone
Sotalol
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents