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

Caen University Hospital

Status: Invitation-only

Conditions: Same-day Discharge; Leadless Pacemaker

Treatments: Device: Leadless pacemaker implantation through right internal jugular vein

Study type: Observational

Funder types: Other

Identifiers

NCT06455566

RYTHMO-2024-01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication of pacemaker implantation
• Eligible to leadless pacemaker

Exclusion criteria

• Contraindication to right internal jugular vein access
• Age < 18 year-old
• Patient already included in a clinical study

Trial design

200 participants in 1 patient group

Leadless pacemaker implantation through right internal jugular vein

Treatment:

Device: Leadless pacemaker implantation through right internal jugular vein