Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05888662
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2023-05-15
Brief Title:
Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy EPIC-VT
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy a Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2023-10
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:
EPIC-VT
Brief Summary:
Radiofrequency ablation of ventricular tachycardias VTs is the gold standard treatment of refractory VTs in patients with ischaemic heart disease In this setting ablation is usually performed endocardially However even after a procedural success there is a high risk of recurrence particularly due to the inability to create transmural lesions Indeed only the endocardium of the LV has been ablated while a significant part of the arrhythmia substrate may be located on the other side of the myocardial thickness on the epicardial side of the LV
First described in 1996 epicardial ablation performed via a percutaneous subxyphoid approach has since undergone considerable development Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle where the substrate is most often epicardial
For VT in ischaemic heart disease electrophysiologists perform endocardial ablation and often perform epicardial ablation only after several endocardial failures Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality it appears essential to optimise rhythm management by ablation by offering a combined approach from the as first approach to reduce the risk of recurrences
The aim of our prospective multicentre controlled randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach
First described in 1996 epicardial ablation performed via a percutaneous subxyphoid approach has since undergone considerable development Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle where the substrate is most often epicardial
For VT in ischaemic heart disease electrophysiologists perform endocardial ablation and often perform epicardial ablation only after several endocardial failures Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality it appears essential to optimise rhythm management by ablation by offering a combined approach from the as first approach to reduce the risk of recurrences
The aim of our prospective multicentre controlled randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach
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