China Valve Registry Study-1

NCT02623907 | Unknown DMC

• 1 other identifier: CHIVAS2015
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Heart Valve Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

AS group

Severe AS patients, without severe AR

AR

Severe AR patients, without severe AS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Wenzhi Pan, M.D.

CONTACT

peden@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 8, 2015
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2020
• Last Updated: December 8, 2015

Record last verified: 2015-12