China Valve Registry Study-1

Aortic Valve Stenosis Clinical Trial

— CHIVAS-1  

Official title:

Registry Study of Aortic Valve Diseases in Chinese Elderly

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02623907
• Other study ID #: CHIVAS2015
• Status: Not yet recruiting
• Phase: N/A
• First received: December 3, 2015
• Last updated: December 7, 2015
• Start date: May 2016
• Est. completion date: May 2020

Study information

• Verified date: December 2015
• Source: Shanghai Zhongshan Hospital
• Contact: Wenzhi Pan, M.D.
• Email: peden[@]sina.com
• Is FDA regulated: No
• Health authority: China:Biomedical Research Ethics Committee of Zhongshan Hospital of Fudan University
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: May 2020
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Heart Defects, Congenital
• Heart Valve Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular (CV) death or hospitalization for heart failure (HF)	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	36 months	Yes
Primary	Surgical or transcatheter aortic valve replacement	from date of enrollment until the date of surgical or transcatheter aortic valve replacement, whichever came first, up to 36 months	36 months	Yes
Secondary	Number of all-cause mortality		from date of enrollment until the date of death for any-cause, up to 36 months	Yes
Secondary	Number of patients developing major cardiovascular and cerebral events (MACCE)		36 moths	Yes