Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05523193
Study type Observational [Patient Registry]
Source Second Affiliated Hospital of Nanchang University
Contact
Status Active, not recruiting
Phase
Start date August 1, 2022
Completion date August 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Completed NCT02241109 - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity N/A
Completed NCT03799133 - Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery N/A
Completed NCT01676727 - ADVANCE Direct Aortic Study
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT00721136 - Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation N/A
Recruiting NCT05044338 - Study on Standard Evaluation System and Optimal Treatment Path of Senile Valvular Heart Disease
Recruiting NCT05014750 - Frailty of Elderly With Valvular Heart Disease and the Short Term Adverse Events
Recruiting NCT05015829 - Diagnostic Impact of Low-dose Dobutamine Echocardiography in Low-flow Low-gradient Aortic Stenosis
Recruiting NCT05078619 - Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation N/A
Recruiting NCT06307262 - European Registry of Transcatheter Repair for Tricuspid Regurgitation
Completed NCT01624870 - CoreValve Advance-II Study: Prospective International Post-market Study
Completed NCT05708690 - Topical Effect of Tranexamic Acid in Postoperative Bleeding and Blood Products Transfusion After Cardiac Surgery Phase 4
Recruiting NCT03797820 - Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly(Mrs AVS)
Recruiting NCT06077721 - Milrinone on Right Ventricular Strain in Cardiac Surgery
Not yet recruiting NCT04632914 - Effect of Trunk Stabilizing Exercises on Patients With Median Sternotomy After Heart Valve Surgery N/A
Completed NCT01477151 - Randomized Isoflurane and Sevoflurane Comparison in Cardiac Surgery Phase 4
Terminated NCT03590730 - Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
Recruiting NCT06204783 - Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort II: Structural Heart Interventions (PLUTO-II)
Enrolling by invitation NCT05775354 - Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project N/A