Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540079
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
BIOTRONIK Conduction System Pacing with the Solia Lead - Solia CSP S
Sponsor:
None
Organization:
None
Study Overview
Official Title:
BIOTRONIK Conduction System Pacing with the Solia Lead
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIO-CONDUCT
Brief Summary:
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area LBBA Safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant Efficacy will be assessed by evaluating implant success rate
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None