International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease with Minimally Impaired Ejection Fraction
NCT ID: NCT06294028
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
268 participants
INTERVENTIONAL
2024-06-12
2029-12-31
Brief Summary
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On the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies.
Finally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Implantation of an automatic defibrillator
Implantation of an automatic defibrillator
Adverse events collection
Collection of deaths from any cause, hospitalizations or emergency consultations for any event related to ventricular arrhythmia or its treatment (recurrence of ventricular tachycardia or complication linked to the defibrillator or crossover from one group to another)
Quality of life questionnaire EQ-5D-5L
Questionnaire on the patient's quality of life and health in 6 questions: on mobility, the person's autonomy, current activities, pain, anxiety. Answers range from "no problem" to "unable" and 5 possible answers to each question.
The last question concerns the patient's health, the patient must rate his or her health on a scale of 0 to 100
Medical-economic evaluation
Collection of expenses incurred by the care of patients in each arm will be collected over a period of 36 months.
Direct medical and non-medical costs as well as costs related to absences from the workplace will be included in the analysis. Healthcare consumption will be collected using the National Health Data System (SNDS).
Percutaneous catheter ablation
Percutaneous catheter ablation
Adverse events collection
Collection of deaths from any cause, hospitalizations or emergency consultations for any event related to ventricular arrhythmia or its treatment (recurrence of ventricular tachycardia or complication linked to the defibrillator or crossover from one group to another)
Quality of life questionnaire EQ-5D-5L
Questionnaire on the patient's quality of life and health in 6 questions: on mobility, the person's autonomy, current activities, pain, anxiety. Answers range from "no problem" to "unable" and 5 possible answers to each question.
The last question concerns the patient's health, the patient must rate his or her health on a scale of 0 to 100
Medical-economic evaluation
Collection of expenses incurred by the care of patients in each arm will be collected over a period of 36 months.
Direct medical and non-medical costs as well as costs related to absences from the workplace will be included in the analysis. Healthcare consumption will be collected using the National Health Data System (SNDS).
Interventions
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Adverse events collection
Collection of deaths from any cause, hospitalizations or emergency consultations for any event related to ventricular arrhythmia or its treatment (recurrence of ventricular tachycardia or complication linked to the defibrillator or crossover from one group to another)
Quality of life questionnaire EQ-5D-5L
Questionnaire on the patient's quality of life and health in 6 questions: on mobility, the person's autonomy, current activities, pain, anxiety. Answers range from "no problem" to "unable" and 5 possible answers to each question.
The last question concerns the patient's health, the patient must rate his or her health on a scale of 0 to 100
Medical-economic evaluation
Collection of expenses incurred by the care of patients in each arm will be collected over a period of 36 months.
Direct medical and non-medical costs as well as costs related to absences from the workplace will be included in the analysis. Healthcare consumption will be collected using the National Health Data System (SNDS).
Eligibility Criteria
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Inclusion Criteria
* sustained monomorphic ventricular tachycardia - without history of syncope or cardiac arrest -
* having signed informed consent
* affiliated to a social security system
Exclusion Criteria
* recent myocardial infarction (\<2 months)
* ventricular tachycardia by reentry from branch to branch
* serious conduction disturbances (with indication of stimulation)
* contraindication to the implantation of a defibrillator or to the performance of an ablation (life expectancy \<1 year, relevant comorbidities)
* pregnancy
* age \<18 years
* Patient under legal protection, guardianship or curatorship
18 Years
90 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Philippe MAURY, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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Rangueil Hospital
Toulouse, France, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC31/21/0338
Identifier Type: -
Identifier Source: org_study_id
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