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

NCT03797820 | Unknown DMC

• 1 other identifier: SAHZJU CT012
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hospitalization for heart failure

  one year

• Surgical or transcatheter aortic valve replacement

  one year

• Cardiovascular death

  one year

Interventions

Our study type is observational OTHER

Our study type is observational

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 60 years old and moderate or above aortic stenosis

You may qualify if:

• \. 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 27908608 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: January 9, 2019
• Study Start: October 1, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

CN (1)