About this trial
Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ischemic heart disease with history of infarction - LVEF> 35% (measured by MRI)
sustained monomorphic ventricular tachycardia - without history of syncope or cardiac arrest -
having signed informed consent
affiliated to a social security system
Disqualifiers
transient regressive cause of ventricular tachycardia
recent myocardial infarction (<2 months)
ventricular tachycardia by reentry from branch to branch
serious conduction disturbances (with indication of stimulation)
Trial design
Parallel
Treatments tested in this trial
Adverse events collection
Other interventionCollection 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
Other interventionQuestionnaire 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
Other interventionCollection 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).
Treatment groups
Trial outcomes
Primary outcomes
Monitoring for the occurrence of at least one serious event during the 36 months of follow-up
Monitoring of the occurrence of death from any cause, hospitalization or emergency consultation 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)
Sponsors and contacts
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