Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
- Conditions
- Same-day DischargeLeadless Pacemaker
- Registration Number
- NCT06455566
- Lead Sponsor
- University Hospital, Caen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
- Indication of pacemaker implantation
- Eligible to leadless pacemaker
- Contraindication to right internal jugular vein access
- Age < 18 year-old
- Patient already included in a clinical study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
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 embolismRate 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.
- Secondary Outcome Measures
Name Time Method Description of procedural characteristics During implantation procedure Procedural characteristics of leadless pacemaker implantation through the jugular vein (duration, position, number of attempts, ...).
Trial Locations
- Locations (13)
Angers University Hospital
🇫🇷Angers, France
Caen University Hospital
🇫🇷Caen, France
Grenoble University Hospital
🇫🇷Grenoble, France
Lille University Hospital
🇫🇷Lille, France
Lyon University Hospital
🇫🇷Lyon, France
Metz-Thionville Regional Hospital
🇫🇷Metz, France
Le Millénaire Private Hospital
🇫🇷Montpellier, France
Les Franciscaines Private Hospital
🇫🇷Nimes, France
Rennes University Hospital
🇫🇷Rennes, France
La Réunion University Hospital
🇫🇷Saint Pierre De La Réunion, France
Scroll for more (3 remaining)Angers University Hospital🇫🇷Angers, France