Evaluation of Clinical Efficacy and Prognosis in Patients with Hypertrophic Obstructive Cardiomyopathy Through Hemodynamic Modeling Reconstructed by CT
NCT06683872 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2024-11-12
Summary
Hypertrophic cardiomyopathy (HCM) is a common autosomal dominant inherited heart disease, with previous data suggesting a prevalence of approximately 1 in 500 in the population. However, with the widespread use of genetic testing and high-sensitivity cardiac imaging in recent years, the estimated prevalence of HCM may be as high as 1 in 200. Approximately 75% of HCM patients will develop left ventricular outflow tract obstruction (LVOTO), leading to decreased exercise capacity, dyspnea, syncope, heart failure, and even sudden death, significantly impacting the patients\' quality of life and survival.
The optimal treatment for hypertrophic obstructive cardiomyopathy (HOCM) is still a matter of controversy, despite surgical myectomy being considered the \"gold standard\" for HOCM treatment. Treatment options such as chemical (radiofrequency) ablation and medications (Mavacamten) are also challenging the status, and there is even debate over the surgical approach for myectomy. Currently, there is no consensus in the medical community about the pathophysiological mechanisms of LVOTO, and the exact mechanisms of its occurrence are not fully understood, which is also a major reason for the treatment controversy in HOCM patients.
The focus of clinical decision-making is on the treatment based on the LVOTO pressure gradient, and it is generally recommended internationally to consider invasive treatment when the LVOTO pressure gradient is ≥50mmHg. However, there are still a small number of patients who do not have symptoms with a pressure gradient greater than 50mmHg or have significant symptoms with a pressure gradient less than 50mmHg, indicating that relying solely on the pressure gradient to assess the severity of HOCM and its prognosis may not be comprehensive enough.
In recent years, with the development of medical engineering integration, the use of computational fluid dynamics (CFD) in the medical field, particularly in the field of cardiovascular diseases, has become increasingly widespread. CFD can construct cardiovascular geometric models based on specific clinical images of a patient and simulate ventricular wall motion and blood flow within the heart through computer calculations to obtain the required hemodynamic parameters. This enables the visualization and quantification of intraventricular blood flow. Compared to direct measurement techniques based on imaging, CFD has advantages such as non-invasiveness, comprehensiveness, and accuracy, leading to its increasing application in cardiovascular function research. In particular, in the field of cardiomyopathy, CFD can help deepen the understanding of the pathophysiological mechanisms of hypertrophic obstructive cardiomyopathy by reconstructing the anatomical configuration of the left ventricle and analyzing intraventricular blood flow and related hemodynamic parameters, which in turn can aid in clinical decision-making and the assessment of clinical prognosis. Therefore, we propose using three-dimensional (3D) computed tomography (CT) simulation technology to assess the hemodynamics of patients with hypertrophic obstructive cardiomyopathy, in order to guide clinical decision-making.
Conditions
- Hypertrophic Cardiomyopathy (HCM)
Interventions
- PROCEDURE
-
surgical myectomy
Our procedure was performed via a right infra-axillary incision (4-5 cm), enter the thoracic cavity through the third intercostal space lateral to the pectoralis major muscle. Generally, neither rib resection nor division of the pectoralis major muscle were required. The intervention utilized femoral-femoral cardiopulmonary bypass (CPB). The aorta was clamped using a Glauber clamp (CardioVision MICAortic Clamp, Cardiomedical GmbH). Myocardial protection was achieved with antegrade Del Nido cardioplegia. After inducing of cardiac asystole, a transverse incision was made in the aorta and the aorta incision was suspended to enhance visualization. A mesh retractor (FEHLING INSTRUMENTS, Karlstein, Germany) was placed in the aortic sinus to protect the aortic leaflets. The extent of the septal myectomy, determined based on preoperative TEE, started 5 mm below the midpoint of the right coronary cusp. It extended counterclockwise towards the anterior commissure of the mitral valve a
Sponsors & Collaborators
-
Zhejiang Provincial People's Hospital
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-01
- Primary Completion
- 2025-08-31
- Completion
- 2026-08-31
Countries
- China
Study Locations
More Related Trials
-
The Clinical Research of the Safety and Effectiveness Evaluation for Using Echocardiography-guided Liwen RF Radiofrequency Ablation System to Treat Hypertrophic Obstructive Cardiomyopathy
NCT04355260 ·Status: UNKNOWN ·Phase: NA
-
Factors Contributing to Increased Left Ventricle Size in Patients With Abnormally Enlarged Hearts
NCT00001878 ·Status: COMPLETED
-
Risk Factors of Postoperative Complications in HCM Patients
NCT04275544 ·Status: UNKNOWN
-
Etiological DiagnOsis of caRdiac Diseases Based on echoCardiograpHIc Images and Clinical Data.
NCT05942729 ·Status: RECRUITING
-
Myocardial Stiffness Evaluation in Patients With Heart Failure With Preserved Ejection Fraction
NCT06196086 ·Status: RECRUITING
-
MCG for Localization of Tachyarrhythmia's Origin
NCT06327425 ·Status: RECRUITING ·Phase: NA
-
Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
NCT04129905 ·Status: COMPLETED ·Phase: NA
-
French Hypertrophic Cardiomyopathy Observatory
NCT01091480 ·Status: RECRUITING
-
Neurohormonal Parameters in Hypertrophic Cardiomyopathies
NCT01729702 ·Status: COMPLETED ·Phase: NA
-
Comparisonof Extended Myoectomy and Myoectomy by Morrow in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM)
NCT02492399 ·Status: UNKNOWN ·Phase: NA
-
Multi-Modality Echocardiographic Techniques in Pathological Left Ventricular Hypertrophy Adults
NCT05719337 ·Status: UNKNOWN
-
Machine Learning Approach Based on Echocardiographic Data to Improve Prediction of Cardiovascular Events in Hypertrophic Cardiomyopathy
NCT06256913 ·Status: RECRUITING
-
Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test
NCT05025644 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's
NCT06290570 ·Status: ACTIVE_NOT_RECRUITING
-
Mechanisms of Right Ventricular Adaptation in Patients With Heart Failure With Preserved Ejection Fraction
NCT04154657 ·Status: UNKNOWN ·Phase: NA
-
Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients
NCT02728739 ·Status: COMPLETED ·Phase: NA
-
The Consistency of Cardiac Output Measurements by Different Methods in VA-ECMO Patients
NCT04102072 ·Status: UNKNOWN ·Phase: NA
-
Heart Failure Ventricular Pressure Time Profile
NCT02791074 ·Status: COMPLETED
-
Characterization of Obesity-related Cardiomyopathy Through Exploration of Human Atrial Trabeculae Contraction
NCT02384252 ·Status: COMPLETED
-
Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy
NCT06391788 ·Status: RECRUITING ·Phase: NA
-
Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction
NCT06282822 ·Status: NOT_YET_RECRUITING
-
The Safety and Influencing Factors of Liwen Procedure in The Treatment of Hypertrophic Cardiomyopathy
NCT06003478 ·Status: UNKNOWN
-
The Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion
NCT05490901 ·Status: RECRUITING
-
Comparison of Peri-procedural Complications of Intracardiac Echocardiography and Transesophageal Echocardiography in Patients With Atrial Fibrillation
NCT05466266 ·Status: UNKNOWN ·Phase: NA
-
Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
NCT04083729 ·Status: UNKNOWN ·Phase: NA