Minimally invasive heart surgery for apical hypertrophic cardiomyopathy
Transapical Beating-heart Myectomy in Patient With Apical Hypertrophic Cardiomyopathy: Safety and Efficacy Results of a Phase I Clinical Trial
This study tests a new, less invasive heart surgery to see if it can help people with apical hypertrophic cardiomyopathy who have severe symptoms that don’t improve with medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05648825 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, safety, and efficacy of a minimally invasive surgical technique called transapical beating-heart myectomy for patients with apical hypertrophic cardiomyopathy. It is a prospective, single-arm, single-center study focusing on patients who have significant heart wall thickening and are experiencing drug-refractory symptoms. The intervention aims to alleviate symptoms and improve heart function without the need for traditional open-heart surgery.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with apical hypertrophic cardiomyopathy who have significant wall thickening and are experiencing severe symptoms despite medication.
Not a fit: Patients with severe heart failure, significant comorbidities requiring open-heart surgery, or those with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients suffering from apical hypertrophic cardiomyopathy.
How similar studies have performed: While this specific approach is novel, similar minimally invasive techniques have shown promise in treating other forms of hypertrophic cardiomyopathy.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Xiang Wei, M.D.
- Email: xiangwei@tjh.tjmu.edu.cn
- Phone: +8613995525956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.