Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594705
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
The JenaValve ALIGN-AR LVAD Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients with Left Ventricular Assist Devices LVAD
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:
JENA-VAD
Brief Summary:
To evaluate the safety and effectiveness of the JenaValve Trilogy Heart Valve System for transcatheter aortic valve replacement TAVR in subjects with continuous flow left ventricular assist devices cfLVAD and clinically significant aortic regurgitation AR who are indicated for TAVR
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