Treatment Adherence and Compliance, Valvular Heart Disease
Conditions
Keywords
Valvular Heart Disease, Valvular regurgitation, Valvular stenosis, TAVI
Brief summary
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
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.
Interventions
OTHERFormal treatment model
Formal treatment model , no further surgery or minimally invasive treatment was performed
Sponsors
Xiao Huang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoints | 1 year after surgery or treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of stroke | 30 days after discharge from hospital after surgery or treatment | The incidence of stroke 30 days after discharge from hospital after surgery or treatment |
| rate of permanent pacemaker implantation | surgery or 30 days after treatment | The rate of permanent pacemaker implantation after surgery or 30 days after treatment |
| Moderate or higher valvular regurgitation | immediately after the surgery or 30 days after discharge | Moderate or higher valvular regurgitation after surgery or 30 days after discharge |
| Readmission rates for aortic stenosis and/or valve implantation-related complications | 30 days and 1 year after surgery or treatment | Readmission rates for aortic stenosis and/or valve implantation-related complications at 30 days and 1 year after surgery or treatment |
| All-cause mortality | surgery or 30 days after treatment | Including cardiac death and non-cardiac death |
| The incidence of abnormal valve position | during operation | including valve displacement, valve embolism, and valve ectopic release |
| The incidence of implantation of two or more valves | during aortic valve replacement | The incidence of implantation of two or more valves during aortic valve replacement |
| The Barthel index | 30 days and 1 year after surgery or treatment | The Barthel index was used to evaluate the health status of the subjects |
| NYHA classification | 30 days and 1 year after discharge after surgery or treatment | NYHA classification at 30 days and 1 year after discharge after surgery or treatment |
| The incidence of intraoperative temporary valve size replacement | intraoperative | including increasing or decreasing valve size |
Countries
China
Outcome results
None listed