A Multicentre Retrospective Study on Bicuspid Aortic Valve

Recruiting

• Conditions: Bicuspid Aortic Valve

• Registration Number: NCT05818722
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief 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 .

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.

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-04-17
• Last Update Submitted: 2023-04-17
• Study First Posted: 2023-04-19
• Last Update Posted: 2023-04-19
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause death	1 year	Death from any causes
Cardical mortality	1 year	Death due to cardiac disease including MI, arrhythmia, heart failure and aortic lesions

Trial Locations

Locations (1)

Affiliated Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China