Myocardial InfarctionPhase 4MANTRA-VTNCT02303639
Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias
A Phase 4 study testing Radiofrequency catheter ablation and Antiarrhythmic drug therapy in people with Myocardial Infarction and Ventricular Tachyarrhythmia, run by Central Finland Hospital District at 2 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Ventricular Tachyarrhythmia
- What is being tested?
- Radiofrequency catheter ablation and Antiarrhythmic drug therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesFinland
- Study dates
- Apr 2015to Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Finland2 sites, 2 recruiting
- Recruiting
Central Finland Central Hospital
Jyväskylä
- Recruiting
Heart Center Tampere University Hospital
Tampere
Heikki Mäkynen, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction, Ventricular Tachyarrhythmia
- Being tested
- Radiofrequency catheter ablation, Antiarrhythmic drug therapy
- Keywords
- implantable cardioverter defibrillator, antiarrhythmic medication, catheter ablation
- Medical subject headings
- Myocardial Infarction, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency catheter ablationProcedure or surgery
Catheter ablation with an open-irrigated tip ablation catheter and 3D electroanatomical mapping
Antiarrhythmic drug therapyDrug
Also called amiodarone, sotalol, class III antiarrhyhtmic agents
Amiodarone (or sotalol) for prevention of VT/VF relapses
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency catheter ablation | Experimental | Radiofrequency catheter ablation using open-irrigated ablation catheter and 3D electroanatomical mapping Receives: Procedure: Radiofrequency catheter ablation |
| Antiarrhythmic drug therapy | Active comparator | Amiodarone (or sotalol) tablet by mouth for the duration of the study Receives: Drug: Antiarrhythmic drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (13)
All cause mortality
Measured: 12 and 24 months
Cardiovascular mortality
Measured: 12 and 24 months
Time to first hospitalization and number of hospital days
Measured: 12 and 24 months
Comparative cost-effectiveness of the therapies
Measured: 12 and 24 months
Quality of life measured By SF-36 and EQ5D questionnaires
Measured: 12 and 24 months
Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires
Measured: 12 and 24 months
Number of appropriate ICD therapies and sustained VT/VF episodes
Measured: 24 months
Number of non-sustained VT episodes
Measured: 12 and 24 months
Number of electrical storm episodes
Measured: 12 and 24 months
Time to first VT/VF
Measured: up to 24 months
Time to reablation
Measured: up to 24 months
Number of inappropriate ICD therapies
Measured: up to 24 months
Number of atrial fibrillation and other supraventricular arrhythmia episodes
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Finland Hospital District
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
- Investigators
- Pekka Raatikainen, MD PhD, Principal investigator, Keski-Suomen sairaanhoitopiiri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303639
- Sponsor's protocol ID
- 7U/2014
- Acronym
- MANTRA-VT
- Status last verified
- Aug 2016
- First submitted
- 21 Nov 2014
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study.
- ClinicalTrials.gov ID
- NCT02303639
- Acronym / sponsor ID
- MANTRA-VT / 7U/2014
- Conditions
- Myocardial Infarction, Ventricular Tachyarrhythmia
- Keywords
- implantable cardioverter defibrillator, antiarrhythmic medication, catheter ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Central Finland Hospital DistrictUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- Apr 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency catheter ablation | Experimental | Procedure: Radiofrequency catheter ablationRadiofrequency catheter ablation using open-irrigated ablation catheter and 3D electroanatomical mapping |
| Antiarrhythmic drug therapy | Active comparator | Drug: Antiarrhythmic drug therapyAmiodarone (or sotalol) tablet by mouth for the duration of the study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency catheter ablationCatheter ablation with an open-irrigated tip ablation catheter and 3D electroanatomical mapping | Procedure or surgery | Radiofrequency catheter ablation |
| Antiarrhythmic drug therapyAlso: amiodarone, sotalol, class III antiarrhyhtmic agentsAmiodarone (or sotalol) for prevention of VT/VF relapses | Drug | Antiarrhythmic drug therapy |
Primary outcome
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
13 secondary outcomes
All cause mortality
Time frame: 12 and 24 months
Cardiovascular mortality
Time frame: 12 and 24 months
Time to first hospitalization and number of hospital days
Time frame: 12 and 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
Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires
Time frame: 12 and 24 months
Number of appropriate ICD therapies and sustained VT/VF episodes
Time frame: 24 months
Number of non-sustained VT episodes
Time frame: 12 and 24 months
Number of electrical storm episodes
Time frame: 12 and 24 months
Time to first VT/VF
Time frame: up to 24 months
Time to reablation
Time frame: up to 24 months
Number of inappropriate ICD therapies
Time frame: up to 24 months
Number of atrial fibrillation and other supraventricular arrhythmia episodes
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pekka Raatikainen, MD PhD principal investigator
Keski-Suomen sairaanhoitopiiri
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Radiofrequency catheter ablation and Antiarrhythmic drug therapy in people with Myocardial Infarction and Ventricular Tachyarrhythmia, run by Central Finland Hospital District at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pekka Raatikainen, MD, PhD (+358503169001, pekka.raatikainen@ksshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2016.