Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06056817
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-09-21
Brief Title:
Chronic Evaluation of Novel Pacemaker System
Sponsor:
Calyan Technologies
Organization:
Calyan Technologies
Study Overview
Official Title:
Chronic Evaluation of Novel Pacemaker System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
The primary study objective is to evaluate the feasibility initial clinical safety and potential effectiveness of the Calyan Pacemaker system
Detailed Description:
This is an early feasibility study designed to evaluate the initial clinical safety device functionality and stability and potential effectiveness of the Calyan pacemaker The Calyan device will be implanted and if acute success criteria are met chronic pacing will be delivered over a 3-month primary follow-up period with subsequent extended follow-up of all patients The data from this study will be used to justify the design of a larger prospective pivotal study that will assess the safety and effectiveness of the Calyan pacemaker device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None