Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391788
• Other study ID #: 2023-ZX013
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Xin Wang
• Phone: 13901036490
• Email: fuwaiwangxin[@]188.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Cardiomyopathy, Hypertrophic Obstructive
• Hypertrophy
• Minimally Invasive Surgery

Intervention

Procedure:
• thoracoscopic Morrow surgery
minimally invasive trans-mitral Morrow septal myectomy
• modified Morrow surgery
median open modified enlarged Morrow septal myectomy

Locations

Country	Name	City	State
China	Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

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