A Study of Chinese Congenital Bicuspid Aortic Valve
ConditionBicuspid Aortic Valve (BAV)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-60
SponsorRuijin Hospital
About this trial
Pervious studies indicated that the prevalence of bicuspid aortic valve（BAV） might be higher in China. There is a familial predisposition to the development of BAV. The study analyzed epidemiological data on selected BAV and established a BAV cohort to observe disease progression and treatment outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patients were aged 14-60 years;
Definitive diagnosis of BAV by imaging (echocardiography, aortic CTA, cardiac magnetic resonance, etc.)
Patients were informed about the nature of the study and agreed to participate in all the terms of the study and signed an informed consent form approved by the ethics committee.
Disqualifiers
Poor patient compliance and inability to complete follow-up visits as required;
Rheumatic heart valve disease, other organic valve disease.
Hyperthyroidism, severe anemia, and other factors that significantly affect hemodynamics.
Other circumstances that the researcher believes should be excluded.
Trial population
This is single-center cohort study. Patients diagnosed with BAV were enrolled in Ruijin Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
SAVR / TAVR
Indications for surgical or transcatheter aortic valve replacement
Time frame
5 yearSecondary outcomes
1
Major adverse cardiovascular events(MACE)
Ascending aortic aneurysm or aortic dissection, all-cause death, cardiac death, non-fatal stroke, hospitalization for heart failure
Time frame
5 yearOther outcomes
1
Synchronized analysis of phonocardiogram and electrocardiogram
Synchronized PCG and ECG data using a wearable cardiac monitoring patch
Time frame
6 or 12 month depending on severity of valves2
Echocardiography
Valve morphology, Degree of valve stenosis or regurgitation, Degree of widening of the ascending aorta, Left ventricular ejection fraction(LVEF) changes, Degree of left ventricular hypertrophy or enlargement.
Time frame
6 or 12 month depending on severity of valvesSponsors and contacts
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Source ClinicalTrials.gov