MedTrace Logo

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

NCT06455566 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-03-26

No results posted yet for this study

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.

Conditions

  • Leadless Pacemaker
  • Same-day Discharge

Interventions

DEVICE

Leadless pacemaker implantation through right internal jugular vein

Leadless pacemaker implantation through right internal jugular vein

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-05-01
Completion
2027-05-01

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06455566 on ClinicalTrials.gov