Valvular Heart Disease in Jiangxi Province (JXVD)

A Real World Study of Valvular Heart Disease in Jiangxi Province

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Valvular Heart Disease; Treatment Adherence and Compliance
• Intervention / Treatment: Other: Formal treatment model

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.

• Study Type: Observational
• Enrollment (Anticipated): 1052

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • The Second Affiliated Hospital of Nanchang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment group; 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; Formal treatment model , no further surgery or minimally invasive treatment was performed
Control group; 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?

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

Collaborators and Investigators

• Sponsor: Xiao Huang
• Investigators: Principal Investigator: Yanqing Wu, President, Second Affiliated Hospital of Nanchang University

Publications and helpful links

General Publications

• Cary T, Pearce J. Aortic stenosis: pathophysiology, diagnosis, and medical management of nonsurgical patients. Crit Care Nurse. 2013 Apr;33(2):58-72. doi: 10.4037/ccn2013820. Review.
• Carita P, Coppola G, Novo G, Caccamo G, Guglielmo M, Balasus F, Novo S, Castrovinci S, Moscarelli M, Fattouch K, Corrado E. Aortic stenosis: insights on pathogenesis and clinical implications. J Geriatr Cardiol. 2016 Sep;13(6):489-98. doi: 10.11909/j.issn.1671-5411.2016.06.001.
• Dweck MR, Boon NA, Newby DE. Calcific aortic stenosis: a disease of the valve and the myocardium. J Am Coll Cardiol. 2012 Nov 6;60(19):1854-63. doi: 10.1016/j.jacc.2012.02.093. Epub 2012 Oct 10. Review.
• Sathyamurthy I, Alex S. Calcific aortic valve disease: is it another face of atherosclerosis? Indian Heart J. 2015 Sep-Oct;67(5):503-6. doi: 10.1016/j.ihj.2015.07.033. Epub 2015 Aug 21.
• Soler-Soler J, Galve E. Worldwide perspective of valve disease. Heart. 2000 Jun;83(6):721-5. doi: 10.1136/heart.83.6.721. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: TAVI; Valvular Heart Disease; Valvular regurgitation; Valvular stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: 2022-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No