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

NCT06455566 | Enrolling By Invitation DMC

• 1 other identifier: RYTHMO-2024-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 13

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.

Conditions

Leadless Pacemaker; Same-day Discharge

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Description of procedural characteristics

  During implantation procedure

Study Arms (1)

Leadless pacemaker implantation through right internal jugular vein

Device: Leadless pacemaker implantation through right internal jugular vein

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Indication of pacemaker implantation
• Eligible to leadless pacemaker

You may not qualify if:

• Contraindication to right internal jugular vein access
• Age \< 18 year-old
• Patient already included in a clinical study

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (13)

Angers University Hospital

Angers, France

Location

Caen University Hospital

Caen, France

Location

Grenoble University Hospital

Grenoble, France

Location

Lille University Hospital

Lille, France

Location

Lyon University Hospital

Lyon, France

Location

Metz-Thionville Regional Hospital

Metz, France

Location

Le Millénaire Private Hospital

Montpellier, France

Location

Les Franciscaines Private Hospital

Nîmes, France

Location

Rennes University Hospital

Rennes, France

Location

La Réunion University Hospital

Saint Pierre de La Réunion, France

Location

Strasbourg University Hospital

Strasbourg, France

Location

Toulouse University Hospital

Toulouse, France

Location

Tours University Hospital

Tours, France

Location

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 12, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)