Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05384418
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2020-11-20
Brief Title:
Cardiac Amyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Cardiac AMyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation CAMPOS-TAVI
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
RECRUITING
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:
CAMPOS-TAVI
Brief Summary:
Aortic stenosis AS is the most frequent valvulopathy in the general population in France and more generally in developed countries due to populations aging Its standard treatment is historically surgical aortic valve replacement SAVR In the 2000s the management of this valvulopathy was revolutionized by the development of the technique of per-cutaneous aortic valve replacement TAVI TAVI opens the possibility of curative treatment to patients at high operational risk not operable by conventional surgery and for whom outcome was affected with high mortality under medical treatment alone
Amyloidosis a pathology with multiple etiologies is a rare condition and its cardiac form AC even more 8 to 17 100000 people year However its prevalence is increasing Some autopsies series have found prevalence up to 50 of cardiac amyloidosis with transthyretin AC-TTR after 60 years In addition recent data suggested that AC-TTR prevalence is higher in the population of patients with heart disease 13 in heart failure with preserved ejection fraction and up to 16 in patients with AS The outcome of patients with AC-TTR remains unknown after TAVI Thus the diagnosis of AC-TTR in patients undergoing TAVI represents an important issue Indeed a treatment stabilizing the process of accumulation of transthyretin deposits effective on the survival of these patients is now available In addition a non-invasive screening strategy for AC-TTR alternative to biopsy is now validated
Amyloidosis a pathology with multiple etiologies is a rare condition and its cardiac form AC even more 8 to 17 100000 people year However its prevalence is increasing Some autopsies series have found prevalence up to 50 of cardiac amyloidosis with transthyretin AC-TTR after 60 years In addition recent data suggested that AC-TTR prevalence is higher in the population of patients with heart disease 13 in heart failure with preserved ejection fraction and up to 16 in patients with AS The outcome of patients with AC-TTR remains unknown after TAVI Thus the diagnosis of AC-TTR in patients undergoing TAVI represents an important issue Indeed a treatment stabilizing the process of accumulation of transthyretin deposits effective on the survival of these patients is now available In addition a non-invasive screening strategy for AC-TTR alternative to biopsy is now validated
Detailed Description:
The aim of the study is to describe prevalence of cardiac amyloidosis with transthyretin in patients undergoing transcatheter aortic valve implantation
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