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

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ClinicalTrials.gov Identifier: NCT03797820
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : July 15, 2021
Sponsor:
Collaborators:
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Wenzhou Medical University
Jinhua Central Hospital
The Second Affiliated Hospital of Jiaxing University
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
The Central Hospital of Lishui City
Sir Run Run Shaw Hospital
Ningbo Medical Center Lihuili Hospital
Ningbo No. 1 Hospital
Information provided by (Responsible Party):
Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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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.

Condition or disease Intervention/treatment
Valvular Heart Disease Other: Our study type is observational

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Prospective, Multicenter,Registry Study of Aortic Valve Stenosis in Zhejiang Elderly
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Our study type is observational
    Our study type is observational

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Hospitalization for heart failure [ Time Frame: one year ]
    time from enrolled to first occurrence of the outcome

  2. Surgical or transcatheter aortic valve replacement [ Time Frame: one year ]
    time from enrolled to first occurrence of the outcome

  3. Cardiovascular death [ Time Frame: one year ]
    time from enrolled to first occurrence of the outcome


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 60 years old and moderate or above aortic stenosis
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797820


Locations
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China, Zhejiang
Second Affiliated Hospital Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Xianbao Liu, MD    +86-13857173887    liuxb2009@hotmail.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Wenzhou Medical University
Jinhua Central Hospital
The Second Affiliated Hospital of Jiaxing University
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
The Central Hospital of Lishui City
Sir Run Run Shaw Hospital
Ningbo Medical Center Lihuili Hospital
Ningbo No. 1 Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

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Responsible Party: Jian'an Wang,MD,PhD, President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03797820    
Other Study ID Numbers: SAHZJU CT012
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Aortic Valve Stenosis
Heart Valve Diseases
 Cardiovascular Diseases
Aortic Valve Disease
Ventricular Outflow Obstruction