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NCT07342608From ClinicalTrials.govRecruiting

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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Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Se | Trialion