Transapical Beating-Heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study

Launched by XIANG WEI · Jul 14, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new heart surgery called transapical beating-heart septal myectomy, which is designed to help patients with a condition known as hypertrophic obstructive cardiomyopathy (HOCM). HOCM can cause the walls of the heart to thicken, making it hard for blood to flow. The goal of this study is to see if this surgery is safe and effective for treating patients who are experiencing significant symptoms that haven't improved with medications. The trial is currently recruiting participants who are between the ages of 29 and 2919.

To be eligible for the trial, patients should have certain heart measurements indicating significant obstruction, as well as symptoms that are serious enough to affect their daily lives. They should also be willing to sign a consent form to participate. However, individuals who are pregnant, have other serious heart problems, or have a life expectancy of less than one year may not qualify. Participants in the trial can expect close monitoring and care from a team of medical professionals throughout the process. This trial represents an important step in finding new treatments for patients with HOCM, and it aims to improve their quality of life.

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.