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Enrolling by Invitation

NCT Number: NCT06455566

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

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.

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Key information

Conditions

Leadless Pacemaker Same-day Discharge

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leadless pacemaker implantation through right internal jugular vein

Device

Leadless pacemaker implantation through right internal jugular vein

Primary outcomes

  1. Rate of effective of jugular access

    Time frame: [0 - 1 Month]

    Feasibility of jugular access for leadless pacemaker implantation, defined as the percentage of patients with a successful leadless pacemaker implantation through the jugular vein.

  2. Rate of effective same-day discharge

    Time frame: [0 - 1 Month]

    Feasibility of same-day discharge after implantation of a leadless pacemaker through the jugular vein, defined as a successful same-day discharge with no readmission during the first postoperative month.

  3. Incidence of major cardiovascular event

    Time frame: [0 - 12 Month]

    Incidence of major complications related to the implantation of a leadless through the jugular vein:

    • pericardial complications (effusion, tamponade, pericardiocentesis)
    • jugular venous complications (bleeding, hematoma, arteriovenous fistula, vascular surgery)
    • carotid artery complications (bleeding, transient ischemic attack or stroke, vascular surgery)
    • pacemaker malfunction
    • infection
    • cardiac rhythm complications (atrioventricular block, ventricular fibrillation ou tachycardia, cardiac arrest)
    • air embolism

Secondary outcomes

  1. Description of procedural characteristics

    Time frame: During implantation procedure

    Procedural characteristics of leadless pacemaker implantation through the jugular vein (duration, position, number of attempts, ...).

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: VAMPIRE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 12, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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