Study Title: A real-world study of valvular heart disease in Jiangxi Province Research Objectives: ① Main objectives: To examine the current incidence of valvular heart disease in Jiangxi Province, to establish a "Formal treatment model" for patients with valvular heart disease, and to manage the collection of diagnostic, therapeutic and prognostic data on patients. ② Secondary objective: To investigate the composite of all-cause mortality, disabling stroke, permanent pacemaker implantation, and moderate or greater valve regurgitation in the "Formal treatment model" group and the "Conventional treatment model" group. The Conventional group was matched to patients who were not in the " Formal treatment model " during the same period. Design type: a prospective, observational, real-world study (at least 1.5 years). No pre-established fixed treatment protocols, only a Formal treatment model,with all treatment choices made entirely by clinicians following relevant textbooks, expert consensus on clinical guidelines, and based on the patient's condition. Subjects: All patients with moderate to severe heart valve disease were collected from the Second Affiliated Hospital of Nanchang University and hospitals at all levels in Jiangxi Province from September 2022 to September 2023.
Summary of Research Protocol: Study Title: A Real World Study of Valvular Heart Disease in Jiangxi Province Research Objectives: ① Main objectives: To examine the current incidence of valvular heart disease in Jiangxi Province, to establish a "Formal treatment model" for patients with valvular heart disease, and to manage the collection of diagnostic, therapeutic and prognostic data on patients. ② Secondary objective: To investigate the composite of all-cause mortality, disabling stroke, permanent pacemaker implantation, and moderate or greater valve regurgitation in the "Formal treatment model" group and the "Conventional treatment model" group. The Conventional group was matched to patients who were not in the " Formal treatment model " during the same period. Design type: a prospective, observational, real-world study (at least 1.5 years). No pre-established fixed treatment protocols, only a Formal treatment model,with all treatment choices made entirely by clinicians following relevant textbooks, expert consensus on clinical guidelines, and based on the patient's condition. Subjects: All patients with moderate to severe heart valve disease were collected from the Second Affiliated Hospital of Nanchang University and hospitals at all levels in Jiangxi Province from September 2022 to September 2023. Formal treatment model group: Patients who agree and accept the surgical treatment recommendation (including medical and surgical treatment) enter the formal treatment model group. Those who have received any of the following treatments (including but not limited to) as recommended by the standardized treatment process are considered to have received the standardized treatment, otherwise, they have not. 1. Surgical procedures: valve repair or replacement, left auricular ligation, left auricular clip. 2. Internal surgery: transcatheter valve replacement, radiofrequency ablation of atrial fibrillation, and left heart ear occlusion. Conventional treatment model group: Patients who do not agree to enter the Formal treatment model group will automatically enter the Conventional treatment model group.
Study Type
OBSERVATIONAL
Enrollment
1,052
Formal treatment model , no further surgery or minimally invasive treatment was performed
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Primary endpoints
all-cause mortality, disabling stroke, and incidence of cardiogenic stroke, permanent pacemaker implantation rate, and moderate or greater valve regurgitation at 1 year after surgery or discharge from treatment
Time frame: 1 year after surgery or treatment
All-cause mortality
Including cardiac death and non-cardiac death
Time frame: surgery or 30 days after treatment
incidence of stroke
The incidence of stroke 30 days after discharge from hospital after surgery or treatment
Time frame: 30 days after discharge from hospital after surgery or treatment
rate of permanent pacemaker implantation
The rate of permanent pacemaker implantation after surgery or 30 days after treatment
Time frame: surgery or 30 days after treatment
Moderate or higher valvular regurgitation
Moderate or higher valvular regurgitation after surgery or 30 days after discharge
Time frame: immediately after the surgery or 30 days after discharge
Readmission rates for aortic stenosis and/or valve implantation-related complications
Readmission rates for aortic stenosis and/or valve implantation-related complications at 30 days and 1 year after surgery or treatment
Time frame: 30 days and 1 year after surgery or treatment
The incidence of intraoperative temporary valve size replacement
including increasing or decreasing valve size
Time frame: intraoperative
The incidence of abnormal valve position
including valve displacement, valve embolism, and valve ectopic release
Time frame: during operation
The incidence of implantation of two or more valves
The incidence of implantation of two or more valves during aortic valve replacement
Time frame: during aortic valve replacement
The Barthel index
The Barthel index was used to evaluate the health status of the subjects
Time frame: 30 days and 1 year after surgery or treatment
NYHA classification
NYHA classification at 30 days and 1 year after discharge after surgery or treatment
Time frame: 30 days and 1 year after discharge after surgery or treatment
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