Ignite Creation Date:
2025-12-18 @ 8:21 AM
Ignite Modification Date:
2025-12-23 @ 11:29 PM
Study NCT ID:
NCT01920815
Status:
None
Last Update Posted:
2018-09-19 00:00:00
First Post:
2013-08-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bicuspid Valve Aortopathy Feasibility Study
Sponsor:
None
Organization:
Study Overview
Official Title:
Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study
Status:
None
Status Verified Date:
2018-09
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:
The study will consider all patients with a bicuspid aortic valve and 1) determine the number of patients needed to be screened for a clinical trial, based on patient eligibility percentages applying specific inclusion and exclusion criteria, 2) for those meeting these criteria, follow changes in and compliance with medical therapy over two years, and 3) in a limited subset of eligible patients, perform MRI at baseline and after 2 years to measure the change in aortic area over time.
Detailed Description:
None
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?: