Trials
Search / Trial NCT05648825

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

Apical Hypertrophic Cardiomyopathy Septal Myectomy Transapical Beating Heart Septal Myectomy Minimally Invasive Midventricular Obstruction And Cavity Obliteration

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.

Locations

Wuhan, Hubei, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

Similar Trials