NCT05648825Active, not recruiting
Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 5 Dec 2022
- Start date
- 15 Nov 2022
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- Xiang Wei
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT05648825
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 15 Nov 2022 to the primary completion date, 30 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-chamber cardiac surgery.
Lab values
- Patients who had severe heart failure with left ventricle ejection fraction \< 50%.
Other
- Patients who were pregnant.
- Patients whose estimated life expectancy \< 12 months.
- Patient who were non-compliant.
- peak VO2 of cardiopulmonary exercise test ≥ 90% of predicted.
- LVOT obstruction.
- 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.
Who the study is looking for
- Patients who were diagnosed as nonobstructive hypertrophic cardiomyopathy, with maximal apical wall thickness ≥ 15 mm.
- Patients with heart function of New York Heart Association ≥ class II.
- Presenting with severe symptoms, e.g. angina, dyspnea, or fatigue, that were unresponsive or intolerant to pharmaceutical therapies;
- Kansas City Cardiomyopathy Questionnaire (KCCQ) score \< 80;
- Presenting with one of the following conditions: midventricular obstruction with gradient ≥ 50 mmHg; grade II or higher diastolic dysfunction; apical aneurysm; ventricular tachycardia that needed an ICD implantation; pulmonary hypertension.
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.