Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595992
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Prospective Observational Cohort Study of Moderate Aortic Valve Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EVOLUTION Prospective Observational Cohort Study of Moderate Aortic Valve Disease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this research is to evaluate and predict the progression of moderate aortic stenosis and regurgitation from clinical characterization biological echocardiographic and computed tomography CT et al Additionally try to analyze the potential impact of device or drug therapy on the progression of the conditions
Detailed Description:
This study is a prospective observational cohort study aimed at thoroughly investigating the disease progression and influencing factors of patients with moderate aortic valve disease diagnosed at the Second Affiliated Hospital of Zhejiang University School of Medicine Aortic valve stenosis and aortic regurgitation are the most common forms of aortic valve disease According to the 2021 ESC guidelines moderate aortic stenosis Moderate AS is defined as an aortic valve area AVA of 10-15 cm2 on echocardiography or AVA lt10 cm2 with an AVA index of 060-085 cm2m2 a peak jet velocity Vmax of 3-4 ms andor a mean transvalvular gradient MG of 20-40 mmHg Moderate aortic regurgitation Moderate AR is defined as a regurgitant fraction between 30 and 50 or an effective regurgitant orifice area between 010-030 cm2
While treatment guidelines for patients with severe AS are well-established there is currently no clear consensus on the treatment of patients with moderate AS and the subsequent disease progression for these patients remains unclear Similarly when the aortic valve shows only moderate regurgitation surgical treatment is usually not required the most important aspect is regular monitoring of disease changes including regular echocardiographic examinations It is noteworthy that the time span from moderate to severe aortic regurgitation can vary from 1 to 10 years and the monitoring and early warning mechanisms for potential markers indicating disease deterioration are currently not well developed The goal of this study is to identify all clinical characterization biological echocardiographic and CT imaging parameters that may increase the risk of disease progression The confirmation of these parameters will guide future research to develop medical and interventional treatment methods to reduce mortality associated with this disease Patients participating in this study will undergo outpatient follow-up every 1 year after diagnosis and will undergo electrocardiography echocardiography blood analysis and enhanced CT examinations at 1 3 and 5 years plus once if an endpoint event occurs Through these comprehensive monitoring methods we expect to more accurately assess changes in the patient39s condition and provide a scientific basis for clinical decision-making
While treatment guidelines for patients with severe AS are well-established there is currently no clear consensus on the treatment of patients with moderate AS and the subsequent disease progression for these patients remains unclear Similarly when the aortic valve shows only moderate regurgitation surgical treatment is usually not required the most important aspect is regular monitoring of disease changes including regular echocardiographic examinations It is noteworthy that the time span from moderate to severe aortic regurgitation can vary from 1 to 10 years and the monitoring and early warning mechanisms for potential markers indicating disease deterioration are currently not well developed The goal of this study is to identify all clinical characterization biological echocardiographic and CT imaging parameters that may increase the risk of disease progression The confirmation of these parameters will guide future research to develop medical and interventional treatment methods to reduce mortality associated with this disease Patients participating in this study will undergo outpatient follow-up every 1 year after diagnosis and will undergo electrocardiography echocardiography blood analysis and enhanced CT examinations at 1 3 and 5 years plus once if an endpoint event occurs Through these comprehensive monitoring methods we expect to more accurately assess changes in the patient39s condition and provide a scientific basis for clinical decision-making
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?:
None