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

Not Applicable

Recruiting

• Conditions: Cardiomyopathy, Hypertrophic Obstructive; Minimally Invasive Surgery
• Interventions: Procedure: thoracoscopic Morrow surgery; Procedure: modified Morrow surgery

• Registration Number: NCT06391788
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-03-31
• Status Verified: 2024-04
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2025-02-01
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracoscopic trans-mitral myectomy	thoracoscopic Morrow surgery	patients who undergo thoracoscopic Morrow procedure
Modified extended Morrow myectomy	modified Morrow surgery	patients who undergo modified extended Morrow myectomy

Primary Outcome Measures

Name	Time	Method
Left ventricular outflow tract gradient variability	6 months,9 months and 12 months	Change in Left ventricular outflow tract gradient pre- and post- intervention

Secondary Outcome Measures

Name	Time	Method
Echocardiographic indicator	6 months,9 months and 12 months	Left ventricular ejection fraction assessed by echocardiography.
6-minute walk distance	6 months,9 months and 12 months	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.
Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score	6 months,9 months and 12 months	A disease-specific health status measure designed to assess the impact of heart failure on patients' quality of life.
Cardiac magnetic resonance indicator	6 months,9 months and 12 months	The left ventricular mass index was assessed using cardiac magnetic resonance imaging.
New York Heart Association Functional Classification of Heart Failure	6 months,9 months and 12 months	A system used to categorize the severity of heart failure based on the functional limitations of individuals.
Marker of myocardial injury	6 months,9 months and 12 months	To assay the concentration of proteins(cardiac troponin T, cardiac troponin I)associated with myocardial injury.

Trial Locations

Locations (1)

Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China