Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-26 @ 4:18 PM
Study NCT ID:
NCT06453850
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2024-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
Sponsor:
MicroPort CRM
Organization:
Study Overview
Official Title:
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POLARIS
Brief Summary:
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: