International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction
Recruiting now · Not applicable
Conditions studied: Ischemic Heart Disease, Ventricular Tachycardia
In brief
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.
Key facts
- Study ID
- NCT06294028
- Run by
- University Hospital, Toulouse
- People needed
- 268
- Starts
- 2024-06-12
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-06-01
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Rangueil Hospital — Toulouse, France, France (enrolling)
Full record on ClinicalTrials.gov
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