International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction

Обзор

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.

Вмешательства

• Другое 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)
• Другое 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
• Другое 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).

Первичные конечные точки

• Monitoring for the occurrence of at least one serious event during the 36 months of follow-up [Срок оценки: 36 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Rangueil Hospital — Toulouse

Идентификаторы

NCT: NCT06294028 · RC31/21/0338

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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