Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455566
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-27
First Post:
2024-06-03
Brief Title:
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
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:
VAMPIRE
Brief Summary:
Leadless pacemakers LP are associated with a lower risk of revision compared with transvenous pacemakers However LPs implantation is associated with a 06 risk of complication at the femoral vein puncture site eg arteriovenous fistula haemorrhage pseudoaneurysm etc As a consequence the need for prolonged in-hospital monitoring after LP implantation though the right femoral RFvein is a barrier to same-day discharge Recently right internal jugular RIJ vein access has emerged an alternative to right RF vein access for LP implantation with a regulatory approval for MEDTRONIC Micra LP
The aims of this registry are the following
evaluate the feasibility of RIJ access for LP implantation
confirm the acute and chronic safety of RIJ access for LP implantation
compare RIJ to RF historical cohort vein access regarding procedural characteristics and outcomes
evaluate the feasibility of same-day discharge avec LP implantation through the RIJ vein
The aims of this registry are the following
evaluate the feasibility of RIJ access for LP implantation
confirm the acute and chronic safety of RIJ access for LP implantation
compare RIJ to RF historical cohort vein access regarding procedural characteristics and outcomes
evaluate the feasibility of same-day discharge avec LP implantation through the RIJ vein
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