China Valve Registry Study-1

Registry Study of Aortic Valve Diseases in Chinese Elderly

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02623907

Acronym

CHIVAS-1

Enrollment

2000

Registered

2015-12-08

Start date

2016-05-31

Completion date

2020-05-31

Last updated

2015-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Valve Diseases

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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

Secondary

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

Contacts

Primary ContactWenzhi Pan, M.D.

peden@sina.com

Outcome results