Ignite Creation Date:
2024-05-06 @ 8:24 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02732691
Status:
UNKNOWN
Last Update Posted:
2022-11-22
First Post:
2016-03-18
Brief Title:
JENAVALVE AS EFS TRIAL Pericardial TAVR Aortic Stenosis Study
Sponsor:
JenaValve Technology Inc
Organization:
JenaValve Technology Inc
Study Overview
Official Title:
JENAVALVE ALIGN-AS TRIAL Safety and EffectivenessPerformance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis AS
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
To collect information about treatment for severe aortic stenosis AS which affects the aortic valve in the heart Aortic stenosis is a narrowing of the aortic valve opening which decreases blood flow from the heart and causes symptoms such as chest pain fainting and shortness of breath The preferred treatment for severe aortic stenosis is aortic valve replacement surgery
Detailed Description:
This study will examine the use of a TAVR Transcatheter Aortic Valve Replacement which is a minimally invasive procedure designed to replace the aortic valve inside the heart This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve In this study TAVR will be performed using the JenaValve Pericardial TAVR System
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA-0010 | OTHER | JenaValve Technology Inc | None |
| P02C220_JV06EFS_CIP | OTHER | None | None |
| CA-0001 EU | OTHER | None | None |
| CA-0001 Germany | OTHER | None | None |