Actively Recruiting
International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease with Minimally Impaired Ejection Fraction
Led by University Hospital, Toulouse · Updated on 2024-10-24
268
Participants Needed
1
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease with Minimally Impaired Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ischemic heart disease with a history of infarction and left ventricular ejection fraction above 35% measured by MRI
- Sustained monomorphic ventricular tachycardia without history of syncope or cardiac arrest
- Signed informed consent
- Affiliated to a social security system
You will not qualify if you...
- Transient regressive cause of ventricular tachycardia
- Recent myocardial infarction less than 2 months ago
- Ventricular tachycardia caused by reentry from branch to branch
- Serious conduction disturbances needing stimulation
- Contraindication for defibrillator implantation or ablation (life expectancy under 1 year, relevant other illnesses)
- Pregnancy
- Age under 18 years
- Patient under legal protection, guardianship, or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rangueil Hospital
Toulouse, France, France, 31059
Actively Recruiting
Research Team
P
Philippe MAURY, MD
CONTACT
A
Audrey TOMASIK
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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