Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy
Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Single-center, Prospective, Open-label, Randomized, Controlled Trial
China National Center for Cardiovascular Diseases
132 participants
Mar 31, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
minimally invasive trans-mitral Morrow septal myectomy
median open modified enlarged Morrow septal myectomy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06391788