Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294028
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-27
Brief Title:
International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease with Minimally Impaired Ejection Fraction
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIVA
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None