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NCT Number: NCT07342608

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

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Left Bundle Branch Area Pacing Left Bundle Branch Pacing Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of LINEA cardiac pacing lead

Device

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

Primary outcomes

  1. LINEA lead complication free rate at 3 months

    Time frame: 3 months after implantation

    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

  2. LINEA lead pacing threshold amplitude at 3 months

    Time frame: 3 months after implantation

    Mean ventricular pacing threshold amplitude

Secondary outcomes

  1. Success rate of LINEA lead minimum sensed amplitude

    Time frame: 3 months after implantation

    Proportion of patients with minimum sensed amplitude ≥ 5 mV

  2. General performances of LINEA lead

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

    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

  3. Safety of the LINEA lead

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

    LINEA lead complication free rate over time, calculated based on number of Adverse Events and Device Deficiencies related to the lead

  4. Safety of the FLEXIGO delivery catheter and the FLEXIGO slitter

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

    FLEXIGO catheter complication free rate, calculated based on number of Adverse Events and Device Deficiencies related to the catheter or the slitter

  5. LINEA lead implantation success rates

    Time frame: Implantation

    Proportion of LINEA leads implanted in the interventricular septum and meeting or not LBBAP criteria

  6. Lead and delivery catheter implantation time

    Time frame: Implantation

    Total procedural time and total fluoroscopic time of each implantation

  7. LINEA lead and FLEXIGO delivery catheter and slitter implantation usability

    Time frame: Implantation

    Handling scores based on a specific questionnaire (scale Very poor/Poor/Acceptable/Good/Very good)

  8. Right Ventricular Autothreshold performances

    Time frame: 3 months after implantation

    • 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

  9. Evolution of LBBAP capture over time

    Time frame: 18 months after implantation

    • LBBAP capture evolution with analyses of ECGs (i.e. V6 R-wave peak time and V6-V1 interpeak interval) and LBBAP criteria collected

Other outcomes

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

    Time frame: 1 month after implantation

    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

  2. Early outcome - LINEA lead pacing threshold amplitude at 1 month

    Time frame: 1 month after implantation

    Mean ventricular pacing threshold amplitude

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

    Time frame: 1 month after implantation

    • 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

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

    Time frame: 1 month after implantation

    • 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)

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

    Time frame: 1 month after implantation

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine Guihard

CONTACT

[email protected]

+33 1 46 01 33 20

Sponsors and collaborators

Lead sponsor

MicroPort CRM

Industry

Registry information

Acronym: STARLIGHT

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Jan 15, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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