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Not yet recruiting NCT07342608

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

No phase Interventional Bradycardia Left Bundle Branch Area Pacing Left Bundle Branch Pacing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Use of LINEA cardiac pacing lead.
Who it may be relevant to
Registry conditions: Bradycardia, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • LINEA lead complication free rate at 3 months [Time frame: 3 months after implantation]
  • LINEA lead pacing threshold amplitude at 3 months [Time frame: 3 months after implantation]
Secondary outcome measures (9)
  • Success rate of LINEA lead minimum sensed amplitude [Time frame: 3 months after implantation]
  • 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]
  • 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]
  • 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]
  • LINEA lead implantation success rates [Time frame: Implantation]
  • Lead and delivery catheter implantation time [Time frame: Implantation]
  • LINEA lead and FLEXIGO delivery catheter and slitter implantation usability [Time frame: Implantation]
  • Right Ventricular Autothreshold performances [Time frame: 3 months after implantation]
  • Evolution of LBBAP capture over time [Time frame: 18 months after implantation]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07342608 · LLAI01 - STARLIGHT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗