Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）

Recruiting

• Conditions: Valvular Heart Disease

• Registration Number: NCT03797820
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Aortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of AVS, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe aortic valve stenosis are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese elderly patients with aortic valve stenosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-12-24
• Study First Submitted QC: 2019-01-05
• Study First Posted: 2019-01-09
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-15
• Primary Completion: 2023-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. Patients over 60 years old meet the following condition moderate or above aortic stenosis as defined by echocardiography: Aortic stenosis, moderate or above, or valve area≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient≥20mmHg

Exclusion Criteria

1. Patients cannot be followed up for any reasons.
2. Patients in critical condition may be die in one year.
3. Patients have been enrolled in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality,disabling strokes and Surgical or transcatheter aortic valve replacement	one year	time from enrolled to first occurrence of any of the components of the composite outcome

Secondary Outcome Measures

Name	Time	Method
Surgical or transcatheter aortic valve replacement	one year	time from enrolled to first occurrence of the outcome
Hospitalization for heart failure	one year	time from enrolled to first occurrence of the outcome
Cardiovascular death	one year	time from enrolled to first occurrence of the outcome

Trial Locations

Locations (1)

Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China