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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06455566

Acronym

VAMPIRE

Enrollment

200

Registered

2024-06-12

Start date

2024-05-01

Completion date

2027-05-01

Last updated

2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leadless Pacemaker, Same-day Discharge

Brief 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.

Interventions

DEVICELeadless pacemaker implantation through right internal jugular vein

Leadless pacemaker implantation through right internal jugular vein

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of effective of jugular access	[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.
Rate of effective same-day discharge	[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.
Incidence of major cardiovascular event	[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

Measure	Time frame	Description
Description of procedural characteristics	During implantation procedure	Procedural characteristics of leadless pacemaker implantation through the jugular vein (duration, position, number of attempts, ...).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026