Transapical Beating-heart Myectomy for the Treatment of Apical Hypertrophic Cardiomyopathy

Launched by XIANG WEI · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new surgical technique called transapical beating-heart myectomy to treat a heart condition known as apical hypertrophic cardiomyopathy. This condition causes certain parts of the heart to become thicker than normal, which can make it hard for the heart to pump blood effectively. The researchers want to see if this surgery is safe and effective for patients who have not found relief from their symptoms through medication.

To participate in this trial, patients need to have been diagnosed with apical hypertrophic cardiomyopathy and have a certain level of heart dysfunction, specifically those who experience significant symptoms despite taking medication. Eligible participants will be informed about the trial and will need to provide their consent before joining. Throughout the study, participants can expect close monitoring and support from the medical team as they undergo this innovative treatment. It's important to note that some individuals, such as those with severe other heart conditions or life expectancy issues, may not be able to take part in the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who were diagnosed as apical hypertrophic cardiomyopathy, with maximal apical 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-chamber cardiac surgery.
• • 3. Patients who had severe heart failure with left ventricle ejection fraction \< 40%.
• • 4. Patients whose estimated life expectancy \< 12 months.
• • 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.

Trial Officials