Ischemic Heart Disease, Ventricular Tachycardia
Conditions
Keywords
Ablation
Brief summary
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.
Interventions
OTHERAdverse 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)
OTHERQuality 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
OTHERMedical-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).
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring for the occurrence of at least one serious event during the 36 months of follow-up | 36 months | 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) |
Countries
France
Contacts
CONTACTPhilippe MAURY, MD
CONTACTAudrey TOMASIK
PRINCIPAL_INVESTIGATORPhilippe MAURY, MD
University Hospital, Toulouse
Outcome results
None listed