Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease (VALVE-COMPASS)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07267117

Acronym

VALVE-COMPASS

Enrollment

10000

Registered

2025-12-05

Start date

2025-06-01

Completion date

2030-05-31

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Aortic Valve Regurgitation, Aortic Valve Stenosis, Heart Valve Disease, Mitral Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Valve Stenosis, Pulmonary Valve Disease, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Edge-to-edge Repair, Transcatheter Pulmonary Valve Replacement (TPVR), Transcatheter Valve Replacement, Tricuspid Valve Disease, Tricuspid Valve Regurgitation

Keywords

Heart Valve Disease Progression, Heart Valve disease sequelae

Brief summary

The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.

Detailed description

This study is a prospective observational cohort study designed to investigate the disease progression, medication and surgical intervention patterns, outcomes, and influencing factors in patients with moderate or greater cardiac valve stenosis and Grade II or higher cardiac valve regurgitation. The study population includes patients diagnosed at 15 major medical institutions in China, including the Second Affiliated Hospital of Zhejiang University School of Medicine and West China Hospital of Sichuan University. The severity of valvular heart disease is determined according to a standardized dataset (JACC Adv. 2025 Apr) developed by a joint task force comprising multiple international societies. Currently, there is a lack of clear consensus regarding the management of patients with moderate valvular stenosis and regurgitation, and their subsequent disease progression remains poorly understood. Notably, the time span for progression from moderate to severe valvular heart disease can vary from 1 to 10 years, and monitoring and early warning mechanisms for potential early markers indicating disease deterioration are currently underdeveloped. Furthermore, patients with severe valvular heart disease may experience different outcomes following various device implantations, and the associated risk factors require further clarification. The objective of this study is to identify all clinical, biological, echocardiographic, and imaging parameters that may increase the risk of disease progression or adverse outcomes through a prospective observational cohort design. The confirmation of these parameters will guide future research in developing pharmacological and interventional treatment strategies to reduce mortality associated with this disease. Patients enrolled in this study will undergo annual outpatient follow-up visits after diagnosis, which will include electrocardiography, echocardiography, blood analysis, and contrast-enhanced CT scans. Through these comprehensive monitoring methods, we aim to accurately assess changes in patients' conditions and provide a scientific basis for clinical decision-making.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least 18 years old; * Be willing and able to provide informed consent to participate in the study; * Patients with heart valve disease diagnosed by echocardiography who meet one of the following criteria: 1. Grade II or higher Aortic valve regurgitation: regurgitant jet width \>3 mm, jet width / LVOT diameter ≥25%, jet cross-sectional area/LVOT cross-sectional area ≥5%, effective regurgitant orifice area (EROA) ≥0.1 cm², regurgitant volume per beat (R Vol)≥30 ml, or regurgitant fraction (RF) ≥30%. 2. Moderate or higher aortic valve stenosis: peak velocity ≥3.0 m/s, Mean gradient ≥20 mm Hg, aortic valve area ≤1.5 cm², Indexed aortic valve area ≤0.85 cm²/m², or velocity ratio ≤0.50. 3. Grade II or higher mitral valve regurgitation: regurgitant jet width ≥3 mm, regurgitant volume per beat ≥30 ml, regurgitant jet area/left atrial area \>30%, or effective regurgitant orifice area (EROA) ≥0.2 cm². 4. Moderate or higher valve stenosis: valve area (specific finding) ≤1.5 cm², or mean gradient (supportive finding) ≥10.0 mmHg. 5. Grade II or higher tricuspid valve regurgitation: regurgitant jet width ≥3 mm, proximal isovelocity surface area ≥6 mm, effective regurgitant orifice area (EROA) ≥0.2 cm², or regurgitant volume per beat ≥30 ml. 6. Significant tricuspid valve stenosis: mean pressure gradient ≥5.0 mmHg, inflow time-velocity integral \>60 cm, T1/2 ≥190 ms, or valve area ≤1.0 cm². 7. Grade II or higher pulmonary valve regurgitation: regurgitant jet width \>3 mm, regurgitant volume per beat ≥30 ml, regurgitant fraction ≥30%, or effective regurgitant orifice area (EROA) ≥0.1 cm². 8. Moderate or higher Pulmonary valve stenosis: pulmonary valve transvalvular pressure gradient ≥40 mmHg, right ventricular systolic pressure ≥60 mmHg, or pulmonary valve opening \<1.5 cm².

Exclusion criteria

* Patients who are unwilling to accept registration and follow-up; * Patients who cannot cooperate with information collection and follow-up due to mental illness or other conditions; * Patients whose life expectancy is less than 12 months due to non-cardiac diseases (such as cancer, liver disease, kidney disease, or end-stage lung disease).

Design outcomes

Primary

Measure	Time frame	Description
All cause mortality	1-year, 2-year, 3-year, 4-year, and 5-year at follow-up	—
Heart valve replacement or repair	1-year, 2-year, 3-year, 4-year, and 5-year at follow-up	Surgical Heart Valve Replacement/Repair or Transcatheter Aortic Valve Replacement/Repair
Stroke	1-year, 2-year, 3-year, 4-year, and 5-year at follow-up	Episode of ischemic stroke or hemorrhagic stroke in the internal carotid artery territory defined on CT scan or MRI brain.
Re-hospitalization related to cardiovascular disease	1-year, 2-year, 3-year, 4-year, and 5-year at follow-up	Requires rehospitalization due to cardiovascular diseases such as coronary atherosclerotic heart disease, heart failure, arrhythmia, pulmonary embolism, aortic disease, and hypertension.

Secondary

Measure	Time frame	Description
Progression of valve stenosis or regurgitation	1-year, 2-year, 3-year, 4-year, and 5-year at follow-up	Progression from moderate valvular stenosis to severe stenosis, or from grade II valvular regurgitation to more severe regurgitation, as defined by the echocardiographic examination.
Ventricular remodeling and deterioration of cardiac function	1-year, 2-year, 3-year, 4-year, and 5-year at follow-up	Changes in indicators such as LVEF, LVEDD, or anteroposterior diameter of the atria as defined by echocardiography
Changes in quality of life and symptoms	1-year, 2-year, 3-year, 4-year, and 5-year at follow-up	NYHA functional class, six-minute walk distance, or newly developed or worsening typical symptoms
Newly Emerging Cardiovascular Disease and Complications	1-year, 2-year, 3-year, 4-year, and 5-year at follow-up	Such as newly onset arrhythmic events (including atrial fibrillation/flutter, conduction block, sick sinus syndrome, etc.), non-hospitalized heart failure-related events, bleeding events, thrombotic events, hypertensive emergencies, and symptoms related to myocardial ischemia.

Countries

China

Outcome results