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: Safety and Efficacy Results of a Phase I First-in-man Clinical Trial

This study is testing a new heart surgery technique for people with hypertrophic obstructive cardiomyopathy to see if it safely helps relieve their symptoms and improves their recovery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 8 Years and up
• Sex: All
• Sponsor: Tongji Hospital (other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05332691 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 utilized to monitor and navigate the surgery, ensuring precise resection and evaluation of outcomes. Patients will be followed up at discharge and three months post-operation to assess their recovery and symptom relief.

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, intrinsic valvular disease, or those who are non-compliant may not benefit from this study.

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 a standard treatment, this specific transapical approach is novel and has not been extensively tested in prior studies.

Eligibility 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)

Study contacts

• Study coordinator: Xiang Wei, M.D.

Conditions: Hypertrophic Obstructive Cardiomyopathy, Septal Myectomy, Systolic Anterior Motion, Left Ventricle Outflow Tract Obstruction, Mitral Regurgitation, Transapical, Off-pump, Minimally invasive