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

NCT ID: NCT07342608

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2030-04-30

Brief 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.

Conditions

Bradycardia; Left Bundle Branch Area Pacing; Left Bundle Branch Pacing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LINEA cardiac pacing lead

Group Type: EXPERIMENTAL

Use of LINEA cardiac pacing lead and FLEXIGO delivery catheter

Intervention Type: DEVICE

Use of LINEA cardiac pacing lead and FLEXIGO delivery catheter for implantation of pacemaker

Interventions

Use of LINEA cardiac pacing lead and FLEXIGO delivery catheter

Use of LINEA cardiac pacing lead and FLEXIGO delivery catheter for implantation of pacemaker

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroPort CRM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Antoine Guihard

Role: CONTACT

antoine.guihard@crm.microport.com

+33 1 46 01 33 20

Other Identifiers

LLAI01 - STARLIGHT

Identifier Type: -

Identifier Source: org_study_id