An interventional study of thoracoscopic Morrow surgery and modified Morrow surgery in Cardiomyopathy, Hypertrophic Obstructive and Minimally Invasive Surgery, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's planned enrollment of 132 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients who undergo thoracoscopic Morrow procedure
Procedure: thoracoscopic Morrow surgery
patients who undergo modified extended Morrow myectomy
Procedure: modified Morrow surgery
minimally invasive trans-mitral Morrow septal myectomy
median open modified enlarged Morrow septal myectomy
Left ventricular outflow tract gradient variability
Change in Left ventricular outflow tract gradient pre- and post- intervention
Time frame: 6 months,9 months and 12 months
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.
Time frame: 6 months,9 months and 12 months
New York Heart Association Functional Classification of Heart Failure
A system used to categorize the severity of heart failure based on the functional limitations of individuals.
Time frame: 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.
Time frame: 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.
Time frame: 6 months,9 months and 12 months
Echocardiographic indicator
Left ventricular ejection fraction assessed by echocardiography.
Time frame: 6 months,9 months and 12 months
Cardiac magnetic resonance indicator
The left ventricular mass index was assessed using cardiac magnetic resonance imaging.
Time frame: 6 months,9 months and 12 months
Plan to share: No
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China National Center for Cardiovascular Diseases