Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620237
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2023-02-08
Brief Title:
BIOMASTERCSP Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pivotal Study of the Amvia Pacemaker and Solia CSP S Pacing Lead on Conduction System Pacing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing LBBAP The patient population consist of patients with cardiac pacemaker indication or cardiac resynchronization therapy indication and intended for implantation of a system with left bundle branch area stimulation Participants will visit sites at enrollment in the study at implantation and pre-hospital discharge 1- 6- and 12-month follow-up visits Additional annual follow-ups may apply until study termination after regulatory approval of Solia CSP S The total duration of the clinical investigation is expected to be until September 2027 with last patient out LPO During the visits the regular pacemaker and lead measurement are performed A 12-lead ECG is recorded to document intrinsic and ventricularly paced heart rhythm to assess left bundle branch area pacing Programming of the pacemakers will be done according to the participants therapeutical needs
The study will be conducted in approximately 18 sites in Europe Australia and New Zealand where more than one physician per site are expected to participate
The study will be conducted in approximately 18 sites in Europe Australia and New Zealand where more than one physician per site are expected to participate
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