Clinical trial NCT03797820: Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）
Official title: A Prospective, Multicenter,Registry Study of Aortic Valve Stenosis in Zhejiang Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Valvular Heart Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Wenzhou Medical University
name: Second Affiliated Hospital of Wenzhou Medical University
name: Jinhua Central Hospital
name: The Second Affiliated Hospital of Jiaxing University
name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
name: The Central Hospital of Lishui City
name: Sir Run Run Shaw Hospital
name: Ningbo Medical Center Lihuili Hospital
name: Ningbo No. 1 Hospital
First posted: 2019-01-09
Enrollment: 1
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 60 years old and moderate or above aortic stenosis

Brief summary: Aortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of AVS, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe aortic valve stenosis are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese elderly patients with aortic valve stenosis.


Eligibility criteria: Inclusion Criteria:

1. Patients over 60 years old meet the following condition moderate or above aortic stenosis as defined by echocardiography: Aortic stenosis, moderate or above, or valve area≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient≥20mmHg

Exclusion Criteria:

1. Patients cannot be followed up for any reasons.
2. Patients in critical condition may be die in one year.
3. Patients have been enrolled in this study.

Primary outcomes:
measure: All-cause mortality,disabling strokes and Surgical or transcatheter aortic valve replacement
timeFrame: one year
Secondary outcomes:
measure: Hospitalization for heart failure
timeFrame: one year
measure: Surgical or transcatheter aortic valve replacement
timeFrame: one year
measure: Cardiovascular death
timeFrame: one year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
citation: Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25.