Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-03-13 @ 9:53 PM
Study NCT ID:
NCT03825406
Status:
WITHDRAWN
Last Update Posted:
2019-03-22
First Post:
2019-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Wildtype Amyloid After TAVR
Sponsor:
North Florida Foundation for Research and Education
Organization:
Study Overview
Official Title:
Prevalence of Wildtype Amyloid Among TAVR Patients With Impaired Hemodynamics
Status:
WITHDRAWN
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Dr. Bavry is recruiting the same patients for a NIH trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Those with abnormal vital signs after TAVR need to be willing to obtain a bone scan to evaluate for wildtype amyloidosis. Positive bone scan findings will require evaluation for primary amyloidosis with blood and urine monoclonal immunoglobulin testing. Primary amyloidosis is a different type of disease which requires different treatment.
Detailed Description:
This research is interested in determining how common wildtype amyloidosis is after transcatheter aortic valve replacement (TAVR). Amyloidosis is a condition characterized by abnormal protein which can accumulate and impair various organs, including the heart. Research suggests that amyloidosis might be common among TAVR patients, but it is a condition that is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their TAVR procedure.
Study Oversight
Has Oversight DMC:
False
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?: