China Valve Registry Study-1

• Conditions: Aortic Valve Insufficiency; Heart Valve Diseases; Aortic Valve Disease; Aortic Valve Stenosis

• Registration Number: NCT02623907
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

With the aging of Chinese population, degenerative valvular disease is becoming more and more frequent, which has brought a heavy burden to our society. Taking aortic stenosis (AS) as an example, the incidence of AS in population over the age of 65 are about 2%, and in population above the age of 85 can be amounted to 4-8%, in the Western country. Since the invention of transcatheter aortic valve replacement (TAVR),aortic valve disease (AVD),including AS and aortic regurgitation (AR), has attracted more and more attention. To date, there are few data about the prevalence of AVD in China. The characteristics and prognosis of AVD in China are still unknown. Therefore, the investigators design a prospective, observational cohort study to investigate characteristics, treatments and prognosis of AVD in Chinese elderly population. The results of the study will provide a basis for the future national health policy for prevention and treatment of AVD in the elderly.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-07
• Last Update Submitted: 2015-12-07
• Study First Posted: 2015-12-08
• Last Update Posted: 2015-12-08
• Study Start: 2016-05
• Primary Completion: 2018-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Severe AS or AR indicated by echocardiography ;
• 60 years old or older.

Exclusion Criteria

• Having both Severe AR and Severe AS;
• Having underwent surgical or transcatheter treatment for AVD;
• Non-degenerative AVD.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical or transcatheter aortic valve replacement	36 months	from date of enrollment until the date of surgical or transcatheter aortic valve replacement, whichever came first, up to 36 months
Cardiovascular (CV) death or hospitalization for heart failure (HF)	36 months	from date of enrollment until the date of first documented HF or date of death from any cause, whichever came first, up to 36 months

Secondary Outcome Measures

Name	Time	Method
Number of all-cause mortality	from date of enrollment until the date of death for any-cause, up to 36 months
Number of patients developing major cardiovascular and cerebral events (MACCE)	36 moths