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This single-center, prospective, open-label, randomized, controlled clinical trial is designed to assess the efficacy and safety of the Thoracoscopic Morrow procedure in the treatment of hypertrophic obstructive cardiomyopathy. The primary objectives include investigating:
Question 1: The efficacy and safety of two surgical modalities in patients presenting with left ventricular outflow tract obstruction and mid-left ventricular hypertrophy.
Question 2: The impact of the two surgical procedures on hemodynamics in patients with left ventricular outflow tract obstruction, mid-left ventricular obstruction, and in individuals with or without organic valvular lesions.
Question 3: The effects of the two surgical procedures on exercise capacity, quality of life, and long-term prognosis among patients with left ventricular outflow tract obstruction and central left ventricular obstruction, both with and without valvular lesions.
Participants will be stratified into two groups. The experimental group will undergo thoracoscopic Morrow surgery, while the control group will undergo median open modified enlarged Morrow surgery.
This study is a single-center, prospective, open-label, randomized, controlled trial designed to investigate the therapeutic value of thoracoscopic Morrow procedure in patients with hypertrophic obstructive cardiomyopathy (HOCM). The study focuses on HOCM patients, with the modified extended Morrow procedure via median sternotomy considered as the 'gold standard treatment' in the control group. The objective is to explore the efficacy of the thoracoscopic Morrow procedure in improving exercise tolerance in HOCM patients, assess the short-term and long-term effectiveness, safety, as well as changes in cardiac function, cardiac structure, and myocardial fibrosis levels associated with thoracoscopic Morrow procedure in treating obstructive HOCM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracoscopic trans-mitral myectomy | Experimental | patients who undergo thoracoscopic Morrow procedure |
|
| Modified extended Morrow myectomy | Active Comparator | patients who undergo modified extended Morrow myectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thoracoscopic Morrow surgery | Procedure | minimally invasive trans-mitral Morrow septal myectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular outflow tract gradient variability | Change in Left ventricular outflow tract gradient pre- and post- intervention | 6 months,9 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk distance | A measure used to assess the functional exercise capacity of individuals. It is determined by the distance a person can walk in 6 minutes on a flat, hard surface. | 6 months,9 months and 12 months |
| New York Heart Association Functional Classification of Heart Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wang | Contact | 13901036490 | fuwaiwangxin@188.com | |
| Lei Song | Contact | 13810532620 | songlqd@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Wang | Fuwai Hospital, National Centre for Cardiovascular Disease | Principal Investigator |
| Lei Song | Fuwai Hospital, National Centre for Cardiovascular Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | China |
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| modified Morrow surgery | Procedure | median open modified enlarged Morrow septal myectomy |
|
A system used to categorize the severity of heart failure based on the functional limitations of individuals. |
| 6 months,9 months and 12 months |
| Marker of myocardial injury | To assay the concentration of proteins(cardiac troponin T, cardiac troponin I)associated with myocardial injury. | 6 months,9 months and 12 months |
| Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score | A disease-specific health status measure designed to assess the impact of heart failure on patients' quality of life. | 6 months,9 months and 12 months |
| Echocardiographic indicator | Left ventricular ejection fraction assessed by echocardiography. | 6 months,9 months and 12 months |
| Cardiac magnetic resonance indicator | The left ventricular mass index was assessed using cardiac magnetic resonance imaging. | 6 months,9 months and 12 months |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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