Clinical Trial

Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum

Study acronym: POLARIS
Recruiting
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Record status
This record was last updated March 6, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
Summary
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-06-05.
Status change: Not Yet Recruiting → Recruiting 2025-03-03
Trial Details
NCT Number NCT06453850
Lead Sponsor MicroPort CRM
Conditions Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing
Enrollment 216 participants
Start Date 2025-02-14
Primary Completion 2025-07 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-06