Ignite Creation Date:
2024-05-06 @ 8:26 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02732704
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-18
First Post:
2016-03-18
Brief Title:
THE ALIGN-AR EFS TRIAL JenaValve Pericardial TAVR Aortic Regurgitation Study
Sponsor:
JenaValve Technology Inc
Organization:
JenaValve Technology Inc
Study Overview
Official Title:
THE ALIGN-AR TRIAL Safety and EffectivenessPerformance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Regurgitation AR
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
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:
To collect information about treatment for severe Aortic Regurgitation AR which affects the aortic valve in the heart Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber Symptoms of aortic regurgitation may include fatigue and shortness of breath The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery
Detailed Description:
This study will examine the use of TAVR Transcatheter Aortic Valve Replacement which is a minimally invasive procedure designed to replace the aortic valve inside the heart In this study TAVR will be performed using the JenaValve Pericardial TAVR System which is intended to help treat severe aortic regurgitation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P02C320_JV06EFS_CIP | OTHER | None | None |
| CA-0002 EU | OTHER | None | None |
| CA-0002 Germany | OTHER | None | None |
| CA-0011 | OTHER | JenaValve Technology Inc | None |