Valvular Heart Disease in Jiangxi Province (JXVD)

Xiao Huang

Status: Active, not recruiting

Conditions: Valvular Heart Disease; Treatment Adherence and Compliance

Treatments: Other: Formal treatment model

Study type: Observational

Funder types: Other

Identifiers

NCT05523193

2022-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,052 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,052 participants in 2 patient groups

Treatment group

Description:

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. 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.

Treatment:

Other: Formal treatment model

Control group

Description:

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.