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ENROLLING BY INVITATION
NCT06455566

Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE

Sponsor: University Hospital, Caen

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2024-05-01

Completion Date

2027-05-01

Last Updated

2025-03-26

Healthy Volunteers

No

Interventions

DEVICE

Leadless pacemaker implantation through right internal jugular vein

Leadless pacemaker implantation through right internal jugular vein

Locations (13)

Angers University Hospital

Angers, France

Caen University Hospital

Caen, France

Grenoble University Hospital

Grenoble, France

Lille University Hospital

Lille, France

Lyon University Hospital

Lyon, France

Metz-Thionville Regional Hospital

Metz, France

Le Millénaire Private Hospital

Montpellier, France

Les Franciscaines Private Hospital

Nîmes, France

Rennes University Hospital

Rennes, France

La Réunion University Hospital

Saint Pierre de La Réunion, France

Strasbourg University Hospital

Strasbourg, France

Toulouse University Hospital

Toulouse, France

Tours University Hospital

Tours, France