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Clinical Trials in France / NCT07342608
Recruiting Not applicable

Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum

NCT07342608 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-06-23
Last updated
2026-09-23

Condition(s) studied

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)

Trial sites (14)

FacilityCityRegionStatus
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 Girona Spain Recruiting
Hospital Universitario Virgen de las Nieves Granada Spain Recruiting
Hospital Universitari i Politècnic La Fe Valencia Spain Recruiting

More MicroPort CRM trials in France

Other trials for the same condition

Official registry record

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.

View NCT07342608 on ClinicalTrials.gov ↗ ← All trials in France