|

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

RECRUITINGN/ASponsored by University Hospital, Toulouse
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Toulouse
Started2024-06-12
Est. completion2029-12-31
Eligibility
Age18 Years – 90 Years
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years – 90 YearsHealthy volunteers accepted
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

Conditions3

Heart DiseaseIschemic Heart DiseaseVentricular Tachycardia

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.