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RecruitingNCT05818722Updated Apr 19, 2023

A Multicentre Retrospective Study on Bicuspid Aortic Valve

An observational study in Bicuspid Aortic Valve, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2023-04-19.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 10 months later.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
1,000
Sex
All
01

Study summary

Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners. Asian populations with BAV have different morphological characteristics from those of the Western populations, and further elucidation of these differences will serve as a guide for the treatment and follow-up of Asian patients. Therefore, we conducted this multicentre retrospective study to analysis the clinical features, long-term development and surgical prognosis of BAV .

Read the detailed description

Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners, and more than one half of patients require medical or surgical treatment within 20 years of diagnosis. Therefore, early diagnosis and effective treatment can help to reduce the incidence of irreversible cardiac impairment and adverse outcomes such as sudden death. Asian populations with BAV have morphological characteristics that differ from those of the Western populations, and further elucidation of these differences could serve as a guide for the treatment and follow-up of Chinese patients. Based on the above background, We conducted this multicentre retrospective study. We will search for patients diagnosed with BAV by echocardiography or other imaging examinations from December 2021 to October 2022 at Nanjing Gulou Hospital, Jiangsu Provincial Hospital and Nanjing Children's Hospital; collect clinical symptoms, signs and examination results of them; find out the specific surgical plan and time of surgery if they have undergone surgery; follow up for symptoms, medication and reexamin Echocardiography to confirm any endpoint events.

02

Conditions studied

  • Bicuspid Aortic Valve

Keywords

  • Bicuspid Aortic Valve
  • Echocardiography
  • Long-term progress
03

In context

Bicuspid Aortic Valve Disease

56 studies on the registry are indexed under Bicuspid Aortic Valve Disease; 24 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 245 across 36 observational studies indexed under Bicuspid Aortic Valve Disease.

Browse Bicuspid Aortic Valve Disease studies →

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Bicuspid Aortic Valve

Inclusion criteria

  • All patients with a suspected diagnosis of Bicuspid Aortic Valve by echocardiogram from December 2021 to October 2022

Exclusion criteria

Exclusion Criteria:

  • Patients with suspected Bicuspid Aortic Valve not clearly diagnosed by echocardiography and not confirmed by cardiac surgery
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. All-cause death

    Death from any causes

    Time frame: 1 year

  2. Cardical mortality

    Death due to cardiac disease including MI, arrhythmia, heart failure and aortic lesions

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Affiliated Drum Tower Hospital of Nanjing University Medical School
    Nanjing, Jiangsu 210008, China
    Recruiting
08

References and documents

Publications

  • Lee M, Sung J, Cho SJ, Choi SH, Cho SW, Oh JK, Park SJ, Kim DK. Aortic dilatation and calcification in asymptomatic patients with bicuspid aortic valve: analysis in a Korean health screening population. Int J Cardiovasc Imaging. 2013 Mar;29(3):553-60. doi: 10.1007/s10554-012-0116-3. Epub 2012 Aug 26. PubMed 22923281 ↗
  • Movahed MR, Hepner AD, Ahmadi-Kashani M. Echocardiographic prevalence of bicuspid aortic valve in the population. Heart Lung Circ. 2006 Oct;15(5):297-9. doi: 10.1016/j.hlc.2006.06.001. Epub 2006 Aug 17. PubMed 16914375 ↗
  • Fedak PWM. Bicuspid aortic valve and the specialty clinic: are your patients at risk? Cardiol Young. 2017 Apr;27(3):411-412. doi: 10.1017/S1047951117000282. Epub 2017 Mar 6. No abstract available. PubMed 28260551 ↗
  • Lo Presti F, Guzzardi DG, Bancone C, Fedak PWM, Della Corte A. The science of BAV aortopathy. Prog Cardiovasc Dis. 2020 Jul-Aug;63(4):465-474. doi: 10.1016/j.pcad.2020.06.009. Epub 2020 Jun 26. PubMed 32599028 ↗
  • Fernandes JF, Gill H, Nio A, Faraci A, Galli V, Marlevi D, Bissell M, Ha H, Rajani R, Mortier P, Myerson SG, Dyverfeldt P, Ebbers T, Nordsletten DA, Lamata P. Non-invasive cardiovascular magnetic resonance assessment of pressure recovery distance after aortic valve stenosis. J Cardiovasc Magn Reson. 2023 Jan 30;25(1):5. doi: 10.1186/s12968-023-00914-3. PubMed 36717885 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05818722
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
The First Affiliated Hospital with Nanjing Medical University, Nanjing Children's Hospital
Responsible party
Sponsor
First posted
Apr 19, 2023
Start date
Dec 1, 2022
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Apr 19, 2023

Study contacts

Jing Yao, Phd
Contact
w1835199709@163.com
+8618905188727
Jing Yao, Phd
study director · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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