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NCT06294028Recruiting

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

Source: ClinicalTrials.gov · Last updated 1 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
268 (estimated)
First submitted
27 Feb 2024
Start date
12 Jun 2024
Primary completion date
31 Dec 2029
Lead sponsor
University Hospital, Toulouse
NCT number
NCT06294028

What you commit to

  • Study type: Interventional
  • Planned participants: 268
  • From 12 Jun 2024 to the primary completion date, 31 Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • recent myocardial infarction (\<2 months)

Age

  • age \<18 years

Other

  • transient regressive cause of ventricular tachycardia
  • 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
  • Patient under legal protection, guardianship or curatorship

Who the study is looking for

  • 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

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rangueil hospital
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.