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

A Prospective, Multicenter,Registry Study of Aortic Valve Stenosis in Zhejiang Elderly

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.

Study Overview

• Status: Recruiting
• Conditions: Valvular Heart Disease
• Intervention / Treatment: Other: Our study type is observational

• Study Type: Observational
• Enrollment (Anticipated): 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 60 years old and moderate or above aortic stenosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Ningbo Medical Center Lihuili Hospital; Second Affiliated Hospital of Wenzhou Medical University; Sir Run Run Shaw Hospital; The Central Hospital of Lishui City; First Affiliated Hospital of Wenzhou Medical University; Ningbo No. 1 Hospital; Jinhua Central Hospital; The Second Affiliated Hospital of Jiaxing University; The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Publications and helpful links

General Publications

• Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25.

Helpful Links

• A hospital-based survey of patients with severe valvular heart disease in China

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: December 24, 2018
• First Submitted That Met QC Criteria: January 5, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Heart Diseases; Aortic Valve Stenosis; Heart Valve Diseases
• Other Study ID Numbers: SAHZJU CT012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No