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

July 14, 2021 updated by: Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 Frame: one year
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 Frame: one year
time from enrolled to first occurrence of the outcome
one year
Surgical or transcatheter aortic valve replacement
Time Frame: one year
time from enrolled to first occurrence of the outcome
one year
Cardiovascular death
Time Frame: one year
time from enrolled to first occurrence of the outcome
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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