Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-01-02 @ 5:42 AM
Study NCT ID:
NCT06722066
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium Registry
Sponsor:
Eunpyeong St. Mary's Hospital
Organization:
Study Overview
Official Title:
Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: Scientific Association of Interventional Cardiology - Transcatheter Aortic Valve Replacement (SAINT-TAVR) Calcium Registry
Status:
RECRUITING
Status Verified Date:
2024-12
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:
SAINT-TAVR Ca
Brief Summary:
The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR). The main question it aims to answer is:
Does the degree of aortic valve annular calcification prior to TAVR influence long-term clinical outcomes, including major adverse cardiovascular events including all-cause mortality, over a 3-year period?
Participants who have undergone TAVR as part of their regular medical care for severe aortic stenosis will have their pre-procedural imaging and clinical outcomes evaluated for a 3-year follow-up period.
Does the degree of aortic valve annular calcification prior to TAVR influence long-term clinical outcomes, including major adverse cardiovascular events including all-cause mortality, over a 3-year period?
Participants who have undergone TAVR as part of their regular medical care for severe aortic stenosis will have their pre-procedural imaging and clinical outcomes evaluated for a 3-year follow-up period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: