Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517537
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Modified Aortic Root Enlargement Procedure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Observational Study of Modified Aortic Root Enlargement Procedure in Aortic Stenosis Patients With Small Aortic Annulus
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This study is a prospective observational clinical trial in which severe AS patients aged 50-70 years with SAA choose modified ARE or TAVR according to their wishes to investigate the safety and efficacy of modified ARE Compare the incidence and clinical outcomes of moderate to severe PPM after modified ARE and TAVR surgery Evaluate the feasibility of postoperative mid valve TAVR and explore the most ideal initial surgical plan for this type of patient from a full lifecycle perspective
Detailed Description:
Small aortic annulus SAA which is prevalently observed in patients with severe aortic stenosis AS constitutes a significant challenge in treatment and may give rise to post-operative prosthetic valve mismatch PPM and an elevated late mortality rate The optimal approach for treating SAA remains controversial Transcatheter aortic valve replacement TAVR has yielded superior valvular hemodynamic outcomes in patients with SAA however the incidence of PPM subsequent to surgery remains considerable Aortic root enlargement ARE represents an effective solution for SAA but the conventional method of aortic ring enlargement for ARE has restricted efficacy In 2021 Yang Bo proposed an enhanced ARE approach where the mitral curtain of the aortic valve was incised in an inverted Y-shape along the left non-coronary junction enabling the enlargement of the number 3-5 of the aortic ring
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