Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMicroPort CRM
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Use of LINEA cardiac pacing lead
Treatment groups
450 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov