Evaluating a new surgical method for treating 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

This study is testing a new surgical method for treating hypertrophic obstructive cardiomyopathy to see if it works better than the traditional approach in helping patients feel better and live healthier lives.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (other gov)
• Locations: 1 site (Beijing)
• Trial ID: NCT06391788 on ClinicalTrials.gov

What this trial studies

This clinical trial is a single-center, prospective, open-label, randomized, controlled study aimed at assessing the efficacy and safety of the thoracoscopic Morrow procedure in patients with hypertrophic obstructive cardiomyopathy (HOCM). Participants will be divided into two groups, one receiving the thoracoscopic approach and the other the traditional modified Morrow procedure. The study will evaluate the impact of these surgical methods on hemodynamics, exercise capacity, quality of life, and long-term prognosis in patients with left ventricular outflow tract obstruction. The trial will also monitor changes in cardiac function and myocardial fibrosis levels associated with the procedures.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with hypertrophic cardiomyopathy and experiencing significant left ventricular outflow tract obstruction despite optimal medical therapy.

Not a fit: Patients who have previously undergone septal reduction therapy or those with severe functional limitations (NYHA class IV) may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive surgical option for patients with hypertrophic obstructive cardiomyopathy, potentially improving their quality of life and long-term outcomes.

How similar studies have performed: While the modified Morrow procedure is established as the gold standard, the thoracoscopic approach is relatively novel, and its efficacy compared to traditional methods has not been extensively tested.

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.

Where this trial is running

Beijing

• Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Xin Wang — Fuwai Hospital, National Centre for Cardiovascular Disease
• Study coordinator: Xin Wang

Conditions: Cardiomyopathy, Hypertrophic Obstructive, Minimally Invasive Surgery