Minimally Invasive Surgery Clinical Trial
Official title:
Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Single-center, Prospective, Open-label, Randomized, Controlled Trial
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.
Status | Recruiting |
Enrollment | 132 |
Est. completion date | March 31, 2025 |
Est. primary completion date | February 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - diagnosed with hypertrophic cardiomyopathy (HCM); - age =18 years old; - presence of left ventricular outflow tract/mid-ventricular obstruction, with a resting left ventricular outflow tract pressure gradient/left ventricular cavity pressure gradient =50 mmHg; significant symptoms persist despite optimal medical therapy, and surgical evaluation indicates the need for intervention; - left ventricular ejection fraction (LVEF) =55%; - signed informed consent, willing and able to return to the hospital for follow-up. Exclusion Criteria: - previously underwent septal reduction therapy (including surgical or interventional procedures); - received or planning to receive an implantable cardioverter-defibrillator (ICD) in the past 3 months; - individuals with concomitant conditions requiring simultaneous surgical intervention; - New York Heart Association (NYHA) functional class IV; - unwilling to undergo surgical treatment; - pregnant or lactating or planning pregnancy; - previously participated in other clinical trials before enrollment; - individuals with concurrent diseases with an expected lifespan of less than 1 year. |
Country | Name | City | State |
---|---|---|---|
China | Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing |
Lead Sponsor | Collaborator |
---|---|
China National Center for Cardiovascular Diseases |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular outflow tract gradient variability | Change in Left ventricular outflow tract gradient pre- and post- intervention | 6 months,9 months and 12 months | |
Secondary | 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 | |
Secondary | 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. | 6 months,9 months and 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Echocardiographic indicator | Left ventricular ejection fraction assessed by echocardiography. | 6 months,9 months and 12 months | |
Secondary | Cardiac magnetic resonance indicator | The left ventricular mass index was assessed using cardiac magnetic resonance imaging. | 6 months,9 months and 12 months |
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