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

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a surgical procedure called thoracoscopic Morrow surgery, which is being tested for patients with a heart condition known as hypertrophic obstructive cardiomyopathy (HCM). HCM is when the heart muscle becomes too thick, making it hard for blood to flow out of the heart. The trial aims to find out if this minimally invasive surgery is effective and safe compared to a traditional, larger surgery. Researchers will look at how well each surgery works, how they affect patients' ability to exercise, their quality of life, and their long-term health.

To be eligible for the trial, participants must be at least 18 years old, have been diagnosed with HCM, and experience significant symptoms even after receiving the best medical treatment. They should also have a specific heart pressure issue that indicates they need surgery. Those who have had certain previous heart surgeries or have other serious health conditions may not be eligible. If someone joins this trial, they will either receive the new thoracoscopic surgery or the traditional surgery, and they will be monitored closely to see how they respond to treatment.

Gender

ALL

Eligibility criteria

• 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.