BradycardiaLeft Bundle Branch Area PacingLeft Bundle Branch Pacing
Investigational drug(s) / intervention(s)
Use of LINEA cardiac pacing lead
Use of LINEA cardiac pacing lead: Use of LINEA cardiac pacing lead and delivery catheter for implantation of pacemaker
Study summary
The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria (phase I and II):
* Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)
* Patient planned for a de novo implantation of an ALIZEA, BOREA or CELEA Single Chamber (SR) or Dual Chamber (DR) pacemaker from MicroPort CRM
* Patient planned for a catheter-guided ventricular pacing lead implantation in the interventricular septum area
* Patient's pacemaker with the remote monitoring functions accepted by the patient and planned to be activated
Exclusion criteria (phase I and II):
* Patient planned for a device upgrade, or a device or a lead replacement
* Patient with a congenital heart disease, hypertrophic cardiomyopathy or infiltrative cardiomyopathy
* Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%
* Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
* Patient having a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient for whom a single dose of steroid eluted by the pacing lead (e.g., dexamethasone sodium phosphate) is contraindicated, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
* Patient with a life expectancy of less than 2 years
* Minor age patient (i.e. under 18 years of age)
* Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
* Non-menopausal women
Primary outcome measure(s)
LINEA lead complication free rate at 3 months — 3 months after implantation Proportion of patients free from complication related to the LINEA lead. A complication is defined as a SADE with a probable or causal relationship to the LINEA lead which triggered an additional invasive intervention or resulted in patient death
LINEA lead pacing threshold amplitude at 3 months — 3 months after implantation Mean ventricular pacing threshold amplitude
Trial sites (14)
Facility
City
Region
Status
Ghent University Hospital
Ghent
Belgium
Recruiting
Centre Hospitalier Annecy Genevois
Annecy
France
Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
France
Recruiting
CHU Grenoble
Grenoble
France
Recruiting
Clinique du Millénaire
Montpellier
France
Recruiting
CHU Rouen Hôpital Charles Nicolle
Rouen
France
Recruiting
Hôpital Trousseau
Tours
France
Recruiting
Ospedale Maggiore della Carità - AO Univ.
Novara
Italy
Recruiting
Ospedale San Cataldo CNR - Fond. Toscana G. Monasterio
Pisa
Italy
Recruiting
ULS de Coimbra
Coimbra
Portugal
Recruiting
ULS Santa Maria
Lisbon
Portugal
Recruiting
Hospital Universitari de Girona Doctor Josep Trueta
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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