LINEA pacing lead for septal placement in pacemaker patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial evaluates a LINEA pacing lead designed for implantation at the interventricular septum in patients requiring de novo pacemaker therapy. It focuses on safety and device performance during and after lead placement in conjunction with ALIZEA, BOREA, or CELEA single- or dual-chamber pacemakers. Eligible participants are adults meeting current ESC pacing guidelines without certain comorbid heart conditions or prior device issues. The study is conducted at multiple European centers and is sponsored by MicroPort CRM.

Why it matters

Who can join: the full rules

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

Where it's running

• Ghent University Hospital
  Ghent, Belgium Recruiting
• Centre Hospitalier Annecy Genevois
  Annecy, France Recruiting
• CHU Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• CHU Grenoble
  Grenoble, France Recruiting
• Clinique du Millénaire
  Montpellier, France Recruiting
• CHU Rouen Hôpital Charles Nicolle
  Rouen, France Recruiting

Study contacts

• Study coordinator: Antoine Guihard
• Email: antoine.guihard@cf.microport.com
• Phone: +33 1 46 01 33 20

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Left bundle branch area pacing with Tendril STS or UltiPace leads

  This study will try left bundle branch area pacing with the Tendril STS or UltiPace lead in adults who need pacemaker leads for bradycardia or related heart conditions to see if pacing and sensing are safe and work through six months after implant.

  Recruiting at 13 sites Abbott Medical Devices · Rio de Janeiro, Rio de Janeiro and 14 other locations · NCT07217392

• Comparing two pacing methods for treating slow heart rates

  This study is testing two different ways to help people with slow heart rates feel better by comparing traditional pacing to a newer method in 2600 patients.

  Recruiting at 45 sites Imperial College London · Dublin and 44 other locations · NCT05815745

• SPIKE FLOW endocardial pacing lead safety and performance study

  This study tests whether the SPIKE FLOW temporary endocardial pacing lead is safe and effective in adults needing temporary pacing during heart-related conditions.

  Recruiting at 2 sites FIAB SpA · Acquaviva delle Fonti, Bari and 2 other locations · NCT07820072

• Factors Linked to Slow Heart Rate After Pulsed Field Ablation for Atrial Fibrillation

  This study looks for factors that might cause bradycardia during the hospital stay after AF ablation using pulsed field technology.

  Recruiting Wroclaw Medical University · Wroclaw, Lower Silesian Voivodeship · NCT07809347

• Transjugular implantation of a leadless pacemaker (Aveir VR) for ventricular pacing

  This study tests whether placing an Aveir VR leadless pacemaker through the neck vein can safely provide ventricular pacing in adults with bradycardia.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT07802119

• Conduction System Pacing Display Research During LBBAP Implant

  Researchers are testing a CSP Display System during left bundle branch area pacing pacemaker implant to see if it accurately shows heart signals compared with a standard ECG.

  Recruiting at 2 sites Medtronic Cardiac Rhythm and Heart Failure · Madurai, Tamil Nadu and 1 other locations · NCT07733960

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.