Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05749107
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-02-18
Brief Title:
In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation Prevalence Mechanisms Advanced Quantification of Regurgitation Severity and Relative Impact of Sinus Rhythm Restoration on the 3D Remodeling of Right Heart Chambers and Tricuspid Valve Apparatus
Status:
RECRUITING
Status Verified Date:
2024-03
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:
ASTRA
Brief Summary:
1050 patients with persistentpermanent atrial fibrillation AF will be studied using conventional and advanced three-dimensional and deformation imaging echocardiography Patients with moderatesevere isolated secondary tricuspid regurgitation STR will undergo blood tests to assess their proteomic profile and cardiac CT to measure the tricuspid annulus geometry The project will aim to 1 assess the prevalence of moderatesevere isolated STR in patients with AF 2 identify the mechanisms associated with the development of moderate-severe STR in patients with AF 3 identify the proteomic profile associated with significant growth of tricuspid valve leaflets as a mechanism to protect patients with AF from the development of moderatesevere STR 4 evaluate the effects of the restoration of sinus rhythm on the severity of STR and the remodeling of the right heart cardiac structures ie right ventricle right atrium and tricuspid valve apparatus
Detailed Description:
None
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