NCT06294028 International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction
| NCT ID | NCT06294028 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Ischemic Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 268 participants |
| Start Date | 2024-06-12 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 268 participants in total. It began in 2024-06-12 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Philippe MAURY, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT06294028 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Ischemic Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06294028 currently recruiting?
Yes, NCT06294028 is actively recruiting participants. Contact the research team at maury.p@chu-toulouse.fr for enrollment information.
Where is the NCT06294028 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT06294028 clinical trial?
NCT06294028 is sponsored by University Hospital, Toulouse. The principal investigator is Philippe MAURY, MD at University Hospital, Toulouse. The trial plans to enroll 268 participants.