Surgery to treat heart issues in patients with nonobstructive hypertrophic cardiomyopathy
Minimally Invasive Transapical Beating-Heart Septal Myectomy in Patients With Nonobstructive Hypertrophic Cardiomyopathy
This study is testing a new heart surgery technique for people with nonobstructive hypertrophic cardiomyopathy to see if it can help relieve their heart failure symptoms when medications don’t work.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 8 Years to 80 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05952154 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, safety, and efficacy of a novel surgical technique called transapical beating-heart septal myectomy for patients suffering from nonobstructive hypertrophic cardiomyopathy. The procedure aims to alleviate drug-refractory heart failure symptoms by performing septal resection through a minimally invasive approach while the heart is still beating. The surgery is guided by real-time echocardiography to ensure precision and safety. The study is a prospective, single-arm, single-center trial conducted at Tongji Hospital.
Who should consider this trial
Good fit: Ideal candidates include patients with a ventricular septal wall thickness of 15 mm or more and New York Heart Association class II heart function who have not responded to drug therapy.
Not a fit: Patients with severe heart failure and a left ventricular ejection fraction below 40% or those with other significant heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with nonobstructive hypertrophic cardiomyopathy who do not respond to medication.
How similar studies have performed: While this approach is innovative, similar surgical techniques have shown promise in treating hypertrophic cardiomyopathy, but this specific method is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients whose maximal ventricular septal 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-heart surgery. 3. Patients who had severe heart failure with left ventricle ejection fraction \< 40%. 4. Patients whose estimated life expectancy \< 12 m. 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.