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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


NCT number NCT06455566
Study type Observational [Patient Registry]
Source University Hospital, Caen
Contact
Status Enrolling by invitation
Phase
Start date May 1, 2024
Completion date May 1, 2027