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

Study acronym: POLARIS
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 5 more changesShow less
    • Trial sites expanded: 3 → 17 locations
    • Study completion date changed from estimate of Dec 2026 to Apr 30, 2026
    • Primary completion date changed from estimate of Jul 2025 to Jun 6, 2025
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 2 of 5 entries
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Primary completion date: Jun 2025 to Jul 2025
    • Start date changed from estimate of Dec 2024 to Feb 14, 2025
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Trial Details
NCT Number NCT06453850
Lead Sponsor MicroPort CRM
Conditions
(from sponsor)		 Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
Related terms Bradycardia
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov