Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
- Bradycardia
- Left Bundle Branch Area Pacing
- Left Bundle Branch Pacing
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- MicroPort CRM
- Enrolment target
- 450
- Started
- 23 June 2026
- Main results due
- 31 January 2027
- Study sites
- 14
- Registry updated
- 23 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(14)
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
Showing 14 of 14 sites. 14 of the 14 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07342608. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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