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

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 Overview

• Status: Not yet recruiting
• Conditions: Bradycardia; Left Bundle Branch Area Pacing; Left Bundle Branch Pacing
• Intervention / Treatment: Device: Use of LINEA cardiac pacing lead

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine Guihard; Phone Number: +33 1 46 01 33 20; Email: antoine.guihard@crm.microport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LINEA cardiac pacing lead	Device: Use of LINEA cardiac pacing lead; Use of LINEA cardiac pacing lead and delivery catheter for implantation of pacemaker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of LINEA lead minimum sensed amplitude	Proportion of patients with minimum sensed amplitude ≥ 5 mV	3 months after implantation
General performances of LINEA lead	Pacing threshold amplitude, impedance and minimum sensed amplitude obtained with the LINEA lead at each patient's visit. LBB pacing threshold amplitude obtained with the LINEA lead during implantation, as well as the chronaxie measurement	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	LINEA lead complication free rate over time, calculated based on number of Adverse Events and Device Deficiencies related to the 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	FLEXIGO catheter complication free rate, calculated based on number of Adverse Events and Device Deficiencies related to the catheter or the 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	Proportion of LINEA leads implanted in the interventricular septum and meeting or not LBBAP criteria	Implantation
Lead and delivery catheter implantation time	Total procedural time and total fluoroscopic time of each implantation	Implantation
LINEA lead and FLEXIGO delivery catheter and slitter implantation usability	Handling scores based on a specific questionnaire (scale Very poor/Poor/Acceptable/Good/Very good)	Implantation
Right Ventricular Autothreshold performances	- Accuracy - Comparison between the manual ventricular pacing threshold performed by a physician and the in-clinic ventricular pacing threshold provided by the RVAT function at the same pulse width and during the same on-site patient's visit	3 months after implantation
Evolution of LBBAP capture over time	- LBBAP capture evolution with analyses of ECGs (i.e. V6 R-wave peak time and V6-V1 interpeak interval) and LBBAP criteria collected	18 months after implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early outcome - Absence of Unanticipated Serious Adverse Device Effect (USADE) related to LINEA lead	Proportion of patients free from USADE. Any event caused by use of the LINEA lead or any accessory packaged with the lead, will be considered as an ADE related to the LINEA lead. The endpoint evaluation will be based on an independent safety events adjudication from a Clinical Events Committee (CEC), based on investigational site reporting	1 month after implantation
Early outcome - LINEA lead pacing threshold amplitude at 1 month	Mean ventricular pacing threshold amplitude	1 month after implantation
Early outcome - Other LINEA lead and FLEXIGO delivery catheter safety and performance	- Implantation success rate - Proportion of LINEA lead successfully implanted at the interventricular septum and fulfilling or not LBBAP success criteria according to the operator's decision	1 month after implantation
Early outcome - Other LINEA lead and FLEXIGO delivery catheter safety and performance	- Short term electrical performances variation - Pacing threshold variation between implantation and 1 month, and electrical performances of the LINEA lead (pacing threshold, impedance and minimum sensed amplitude)	1 month after implantation
Early outcome - Other LINEA lead and FLEXIGO delivery catheter safety and performance	- Complication free rate - 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	1 month after implantation

Collaborators and Investigators

• Sponsor: MicroPort CRM

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Bradycardia
• Other Study ID Numbers: LLAI01 - STARLIGHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No