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

NCT07342608 | Not Yet Recruiting DMC

• 1 other identifier: LLAI01 - STARLIGHT
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• LINEA lead complication free rate at 3 months

  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

  3 months after implantation

• LINEA lead pacing threshold amplitude at 3 months

  Mean ventricular pacing threshold amplitude

  3 months after implantation

Secondary Outcomes (9)

• Success rate of LINEA lead minimum sensed amplitude

  3 months after implantation

• General performances of LINEA lead

  Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation

• Safety of the LINEA lead

  Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation

• Safety of the FLEXIGO delivery catheter and the FLEXIGO slitter

  Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation

• LINEA lead implantation success rates

  Implantation

Other Outcomes (5)

• Early outcome - Absence of Unanticipated Serious Adverse Device Effect (USADE) related to LINEA lead

  1 month after implantation

• Early outcome - LINEA lead pacing threshold amplitude at 1 month

  1 month after implantation

• Early outcome - Other LINEA lead and FLEXIGO delivery catheter safety and performance

  1 month after implantation

Study Arms (1)

LINEA cardiac pacing lead

EXPERIMENTAL

Device: Use of LINEA cardiac pacing lead

Interventions

Use of LINEA cardiac pacing lead DEVICE

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

LINEA cardiac pacing lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroPort CRM: lead

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Antoine Guihard

CONTACT

+33 1 46 01 33 20; antoine.guihard@crm.microport.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 15, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share