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Enrolling by invitation NCT06455566

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

— Observational Leadless Pacemaker Same-day Discharge

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Leadless pacemaker implantation through right internal jugular vein.
Who it may be relevant to
Registry conditions: Leadless Pacemaker, Same-day Discharge. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device Leadless pacemaker implantation through right internal jugular vein
    Leadless pacemaker implantation through right internal jugular vein

Primary outcome measures

  • Rate of effective of jugular access [Time frame: [0 - 1 Month]]
  • Rate of effective same-day discharge [Time frame: [0 - 1 Month]]
  • Incidence of major cardiovascular event [Time frame: [0 - 12 Month]]
Secondary outcome measures (1)
  • Description of procedural characteristics [Time frame: During implantation procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 13 centers
  • Angers University Hospital — Angers
  • Caen University Hospital — Caen
  • Grenoble University Hospital — Grenoble
  • Lille University Hospital — Lille
  • Lyon University Hospital — Lyon
  • Metz-Thionville Regional Hospital — Metz
  • Le Millénaire Private Hospital — Montpellier
  • Les Franciscaines Private Hospital — Nîmes
  • … and 5 more centers

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. PMID 38426911
  • 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. PMID 30653690
  • 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. PMID 36031774

Identifiers

NCT: NCT06455566 · RYTHMO-2024-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗