Valvular Heart Disease in Jiangxi Province

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Surgical procedures: valve repair or replacement, left auricular ligation, left auricular clip. 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.

Official Title
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A Real World Study of Valvular Heart Disease in Jiangxi Province

Conditions
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Valvular Heart Disease, Treatment Adherence and Compliance

Intervention / Treatment
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* Other: Formal treatment model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All moderate-to-severe heart valve disease, including aortic, mitral, and tricuspid valves; Comply with the ESC/EACTS Guidelines for the Management of Valvular Heart Disease (2021) indications for surgery for valvular heart disease; Understand and voluntarily sign the informed consent form Exclusion Criteria: those with severe mental disorders and unable to express their will; those with obvious other abnormal signs, laboratory tests and clinical diseases that, in the judgment of the investigator, make them unsuitable for participation in the study; those who, in the judgment of the investigator, are unable to complete long-term follow-up.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment group<br>Treatment group (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. Surgical procedures: valve repair or replacement, left auricular ligation, left auricular clip. Internal surgery: transcatheter valve replacement, radiofrequency ablation of atrial fibrillation, and left heart ear occlusion. | Other: Formal treatment model<br>* Formal treatment model , no further surgery or minimally invasive treatment was performed<br>|
| Control group<br>Control group（Conventional treatment model group）:Patients who do not agree to enter the Formal treatment model group will automatically enter the Conventional treatment model group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year after surgery or treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Including cardiac death and non-cardiac death | surgery or 30 days after treatment | 
| incidence of stroke | The incidence of stroke 30 days after discharge from hospital after surgery or treatment | 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 | surgery or 30 days after treatment | 
| Moderate or higher valvular regurgitation | Moderate or higher valvular regurgitation after surgery or 30 days after discharge | 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 | 30 days and 1 year after surgery or treatment | 
| The incidence of intraoperative temporary valve size replacement | including increasing or decreasing valve size | intraoperative | 
| The incidence of abnormal valve position | including valve displacement, valve embolism, and valve ectopic release | during operation | 
| The incidence of implantation of two or more valves | The incidence of implantation of two or more valves during aortic valve replacement | during aortic valve replacement | 
| The Barthel index | The Barthel index was used to evaluate the health status of the subjects | 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 | 30 days and 1 year after discharge after surgery or treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Valvular Heart Disease, Valvular regurgitation, Valvular stenosis