Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy

Launched by XIANG WEI · Apr 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical approach called transapical beating-heart septal myectomy, aimed at treating a heart condition known as hypertrophic obstructive cardiomyopathy (HOCM). HOCM occurs when the heart muscle becomes abnormally thick, making it hard for blood to flow out of the heart. The study seeks to determine if this procedure is safe and effective for patients who have significant symptoms and have not found relief from medications.

To participate in this trial, patients need to have certain heart measurements, specifically a high pressure in the heart's outflow tract and thickened heart walls. They should also have moderate to severe symptoms that affect their daily life. Unfortunately, this trial is not open to pregnant women or those with other serious heart diseases requiring different surgeries. Participants will be closely monitored throughout the study to assess the outcomes and any potential side effects of the surgery. Overall, this trial represents an important step in finding new treatment options for patients struggling with HOCM.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients whose resting or provoked left ventricular outflow tract gradient \> 50 mmHg, and maximal ventricular septal wall thickness ≥ 15 mm.
• • 2. Patients with heart function of New York Heart Association ≥ class II.
• • 3. Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
• • 4. Patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form.
• Exclusion Criteria:
• • 1. Patients who were pregnant.
• • 2. Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
• • 3. Patients who had severe heart failure with left ventricle ejection fraction \< 40%.
• • 4. Patients whose estimated life expectancy \< 12 m.
• • 5. Patient who were non-compliant.
• • 6. Patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.