Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06455566
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-26
First Post:
2024-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Sponsor:
University Hospital, Caen
Organization:
Study Overview
Official Title:
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-02
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 0.6% risk of complication at the femoral vein puncture site (e.g. arteriovenous fistula, haemorrhage, pseudoaneurysm, etc.). As a consequence, the need for prolonged in-hospital monitoring after LP implantation though the right femoral (RF)vein 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:
True
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?: