Clinical Research Directory
Browse clinical research sites, groups, and studies.
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Sponsor: University Hospital, Caen
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
Conditions
Interventions
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