Clinical trial NCT06455566: Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Official title: Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Leadless Pacemaker
Same-day Discharge
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with a guideline-based pacemaker indication and eligible to leadless pacemaker implantation.

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.


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

Primary outcomes:
measure: Rate of effective of jugular access
timeFrame: [0 - 1 Month]
measure: Rate of effective same-day discharge
timeFrame: [0 - 1 Month]
measure: Incidence of major cardiovascular event
timeFrame: [0 - 12 Month]
Secondary outcomes:
measure: Description of procedural characteristics
timeFrame: During implantation procedure
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Lyon
country: France
facility: Lyon University Hospital
city: Metz
country: France
facility: Metz-Thionville Regional Hospital
city: Montpellier
country: France
facility: Le Millénaire Private Hospital
city: Nimes
country: France
facility: Les Franciscaines Private Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Saint Pierre De La Réunion
country: France
facility: La Réunion University Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.