China Valve Registry Study-1 (CHIVAS-1)

Registry Study of Aortic Valve Diseases in Chinese Elderly

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients aging more than 60 years diagnosed with severe AS or AR by echocardiography will be collected from multiple institutions.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
AS group; Severe AS patients, without severe AR
AR; Severe AR patients, without severe AS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: December 3, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Estimate): December 8, 2015
• Last Update Submitted That Met QC Criteria: December 7, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Ventricular Outflow Obstruction; Cardiovascular Abnormalities; Aortic Valve Stenosis; Aortic Valve Insufficiency; Heart Defects, Congenital; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: CHIVAS2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED