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Clinical Trials/NCT05818722
NCT05818722
Recruiting
Not Applicable

Multicentre Retrospective Analysis of the Characteristics and the Long-term Prognosis of the Bicuspid Aortic Valve

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country1,000 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bicuspid Aortic Valve
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment
1000
Locations
1
Primary Endpoint
All-cause death
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 1, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

All-cause death

Time Frame: 1 year

Death from any causes

Cardical mortality

Time Frame: 1 year

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

Study Sites (1)

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