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

RecruitingNAAges 18 Years - 90 YearsAllUniversity Hospital, Toulouse
NCT06294028 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 implantati

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📋 Eligibility rules (as published)
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
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What it tests

  • Adverse events collection
  • Quality of life questionnaire EQ-5D-5L
  • Medical-economic evaluation
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Where

1 site
Rangueil Hospital
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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