Transapical Beating-heart Myectomy for the Treatment of Apical Hypertrophic Cardiomyopathy
Launched by XIANG WEI · Dec 5, 2022
Trial Information
Current as of January 21, 2025
Recruiting
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
Xiang Wei, M.D.
Study Chair
Tongji Hospital
About Xiang Wei
Xiang Wei is a leading clinical trial sponsor dedicated to advancing medical research and innovation. With a strong focus on developing novel therapies, the organization collaborates with a diverse network of healthcare professionals and institutions to conduct rigorous clinical studies across various therapeutic areas. Committed to ethical practices and patient-centered approaches, Xiang Wei emphasizes transparency and scientific integrity in all its initiatives, striving to bring safe and effective treatments to market. Through its comprehensive expertise and a robust infrastructure, Xiang Wei aims to enhance healthcare outcomes and contribute to the global understanding of complex diseases.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wuhan, Hubei, China
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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