New heart surgery technique for patients with hypertrophic obstructive cardiomyopathy
Minimally Invasive Transapical Septal Myectomy in the Beating Hearts for the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study
This study is testing a new heart surgery technique for people with hypertrophic obstructive cardiomyopathy to see if it can safely relieve their symptoms with less damage to the heart.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 8 Years to 80 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05957419 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, safety, and efficacy of a novel transapical beating-heart septal myectomy for treating hypertrophic obstructive cardiomyopathy. The procedure aims to relieve left ventricle outflow tract obstruction while minimizing surgical injury through a mini-thoracotomy approach. Real-time echocardiography is used to monitor and guide the surgery, allowing for tailored resections to address both obstruction and mitral regurgitation. Participants will be followed up at discharge and three months post-operation to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with significant left ventricular outflow tract obstruction and drug-refractory symptoms.
Not a fit: Patients with severe heart failure or those requiring concurrent open-heart surgery may not benefit from this procedure.
Why it matters
Potential benefit: If successful, this technique could provide a safer and more effective surgical option for patients suffering from hypertrophic obstructive cardiomyopathy.
How similar studies have performed: While surgical septal myectomy is established, this specific transapical approach is novel and has not been widely tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients whose resting or provoked left ventricular outflow tract gradient \> 50 mmHg, and 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)
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.