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

MicroPort

Status

Begins enrollment in 1 month

Conditions

Bradycardia

Left Bundle Branch Pacing

Left Bundle Branch Area Pacing

Treatments

Device: Use of LINEA cardiac pacing lead and FLEXIGO delivery catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT07342608

LLAI01 - STARLIGHT

Details and patient eligibility

About

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.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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