NCT07342608 Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
| NCT ID | NCT07342608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MicroPort CRM |
| Condition | Bradycardia |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2026-06-23 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2026-06-23 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07342608 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bradycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07342608 currently recruiting?
Yes, NCT07342608 is actively recruiting participants. Contact the research team at antoine.guihard@cf.microport.com for enrollment information.
Where is the NCT07342608 trial being conducted?
This trial is being conducted at Ghent, Belgium, Annecy, France, Clermont-Ferrand, France, Grenoble, France and 10 additional locations.
Who is sponsoring the NCT07342608 clinical trial?
NCT07342608 is sponsored by MicroPort CRM. The trial plans to enroll 450 participants.