Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864145
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2021-04-24
Brief Title:
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
Sponsor:
Nanjing First Hospital Nanjing Medical University
Organization:
Nanjing First Hospital Nanjing Medical University
Study Overview
Official Title:
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation a Prospective Multicenter Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
SEASON-AR
Brief Summary:
Prospective multicenter randomized trial
Detailed Description:
Patients with severe native aortic valve regurgitation AR who have symptoms impaired LVEF 55 or left ventricular enlargement have the indications for surgery According to data from the Euro Heart Survey only 218 with LVEF 30-50 and 27 with LVEF 30 were referred for surgical aortic valve replacement SAVR among patients with severe native aortic regurgitation Advanced age and comorbidities were often considered as main reasons to refuse SAVR The annual mortality of untreated patients with severe AR is 10-20 Pure native AR is always an exclusion criterion in all randomized controlled trials on transcatheter aortic valve implantation TAVR because the specific anatomical features can preclude adequate valve implantation Several small retrospective studies showed that off-label use of TAVR appears to be a feasible treatment choice for AR patients at high risk for SAVR The present study aims to investigate the use of TAVR in AR patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None