Aortic Valve DiseaseCHIVAS-1NCT02623907
China Valve Registry Study-1
An observational study of Aortic Valve Disease and Aortic Valve Stenosis, run by Shanghai Zhongshan Hospital.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aging more than 60 years diagnosed with severe AS or AR by echocardiography will be collected from multiple institutions.
Who may be able to join
- Severe AS or AR indicated by echocardiography ;
- 60 years old or older.
Who cannot join
- Having both Severe AR and Severe AS;
- Having underwent surgical or transcatheter treatment for AVD;
- Non-degenerative AVD.
Trial locations and contacts
No sites are listed yet.
Wenzhi Pan, M.D. contact
About this study
Official title: 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.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency, Heart Valve Diseases
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AS group | Severe AS patients, without severe AR | |
| AR | Severe AR patients, without severe AS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 36 months
Secondary outcomes (2)
Number of all-cause mortality
Measured: 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)
Measured: 36 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startMay 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623907
- Sponsor's protocol ID
- CHIVAS2015
- Acronym
- CHIVAS-1
- Status last verified
- Dec 2015
- First submitted
- 3 Dec 2015
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study of Aortic Valve Diseases in Chinese Elderly
- ClinicalTrials.gov ID
- NCT02623907
- Acronym / sponsor ID
- CHIVAS-1 / CHIVAS2015
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency, Heart Valve Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AS group | – | –Severe AS patients, without severe AR |
| AR | – | –Severe AR patients, without severe AS |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aging more than 60 years diagnosed with severe AS or AR by echocardiography will be collected from multiple institutions.
Key inclusion criteria (2 listed)
- Severe AS or AR indicated by echocardiography ;
- 60 years old or older.
Key exclusion criteria (3 listed)
- Having both Severe AR and Severe AS;
- Having underwent surgical or transcatheter treatment for AVD;
- Non-degenerative AVD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular (CV) death or hospitalization for heart failure (HF)
Time frame: 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
Time frame: 36 months
from date of enrollment until the date of surgical or transcatheter aortic valve replacement, whichever came first, up to 36 months
2 secondary outcomes
Number of all-cause mortality
Time frame: 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)
Time frame: 36 moths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenzhi Pan, M.D. contact
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease and Aortic Valve Stenosis, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenzhi Pan, M.D. (peden@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular (CV) death or hospitalization for heart failure (HF) (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.