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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Rangueil Hospital
RECRUITING
Toulouse
Contact Information
Primary
Philippe MAURY, MD
maury.p@chu-toulouse.fr
5 61 34 10 18
Backup
Audrey TOMASIK
tomasik.a@chu-toulouse.fr
5 61 77 85 97
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 268
Treatments
Active_comparator: Implantation of an automatic defibrillator
Implantation of an automatic defibrillator
Experimental: Percutaneous catheter ablation
Percutaneous catheter ablation
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov