International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Def
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 lo
| Condition(s) | Ischemic Heart Disease, Ventricular Tachycardia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Lead sponsor | University Hospital, Toulouse |
| Locations | Toulouse, France, France |
| Start date | 2024-06-12 |
| NCT ID | NCT06294028 |
| Official listing | https://clinicaltrials.gov/study/NCT06294028 |