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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Same-day Discharge; Leadless Pacemaker
• Intervention / Treatment: Device: Leadless pacemaker implantation through right internal jugular vein

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Angers University Hospital
  • Caen, France
    • Caen University Hospital
  • Grenoble, France
    • Grenoble University Hospital
  • Lille, France
    • Lille University Hospital
  • Lyon, France
    • Lyon University Hospital
  • Metz, France
    • Metz-Thionville Regional Hospital
  • Montpellier, France
    • Le Millénaire Private Hospital
  • Nimes, France
    • Les Franciscaines Private Hospital
  • Rennes, France
    • Rennes University Hospital
  • Saint Pierre De La Réunion, France
    • La Réunion University Hospital
  • Strasbourg, France
    • Strasbourg University Hospital
  • Toulouse, France
    • Toulouse University Hospital
  • Tours, France
    • Tours University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consecutive patients with a guideline-based pacemaker indication and eligible to leadless pacemaker implantation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Leadless pacemaker implantation through right internal jugular vein	Device: Leadless pacemaker implantation through right internal jugular vein; Leadless pacemaker implantation through right internal jugular vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of effective of jugular access	Feasibility of jugular access for leadless pacemaker implantation, defined as the percentage of patients with a successful leadless pacemaker implantation through the jugular vein.	[0 - 1 Month]
Rate of effective same-day discharge	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.	[0 - 1 Month]
Incidence of major cardiovascular event	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	[0 - 12 Month]

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Publications and helpful links

General Publications

• El-Chami MF, Garweg C, Clementy N, Al-Samadi F, Iacopino S, Martinez-Sande JL, Roberts PR, Tondo C, Johansen JB, Vinolas-Prat X, Cha YM, Grubman E, Bordachar P, Stromberg K, Fagan DH, Piccini JP. Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry. Eur Heart J. 2024 Apr 7;45(14):1241-1251. doi: 10.1093/eurheartj/ehae101.
• Saleem-Talib S, van Driel VJ, Chaldoupi SM, Nikolic T, van Wessel H, Borleffs CJW, Ramanna H. Leadless pacing: Going for the jugular. Pacing Clin Electrophysiol. 2019 Apr;42(4):395-399. doi: 10.1111/pace.13607. Epub 2019 Feb 25.
• Saleem-Talib S, van Driel VJ, Nikolic T, van Wessel H, Louman H, Borleffs CJW, van der Heijden J, Cox M, Ramanna H. The jugular approach for leadless pacing: A novel and safe alternative. Pacing Clin Electrophysiol. 2022 Oct;45(10):1248-1254. doi: 10.1111/pace.14587. Epub 2022 Sep 12.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RYTHMO-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No