Transapical Beating-Heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Interventions
- Procedure: Transapical beating-heart septal myectomy
- Registration Number
- NCT05957419
- Lead Sponsor
- Xiang Wei
- Brief Summary
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy. This is a prospective, single-arm, multi-center study.
- Detailed Description
Surgical septal myectomy remains the gold standard for the treatment of hypertrophic obstructive cardiomyopathy. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient relieve the obstruction of the left ventricle outflow tract while guarantee safety. To increase the visualization and minimize the surgical injury of conventional septal myectomy, the investigators have invented a novel beating-heart myectomy device. Through a mini-thoractomy, septal myectomy could be accomplished via a transapical access in the beating heart using the beating-heart myectomy device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricle outflow tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor sufficient relief of left ventricle outflow tract obstruction and mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, participants is scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Patients whose resting or provoked left ventricular outflow tract gradient > 50 mmHg, and maximal ventricular septal wall thickness ≥ 15 mm.
- Patients with heart function of New York Heart Association ≥ class II.
- Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
- 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
- Patients who were pregnant.
- Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
- Patients who had severe heart failure with left ventricle ejection fraction < 40%.
- Patients whose estimated life expectancy < 12 m.
- Patient who were non-compliant.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hypertrophic Obstructive Cardiomyopathy Transapical beating-heart septal myectomy Transapical beating-heart septal myectomy for the patient with hypertrophic obstructive cardiomyopathy.
- Primary Outcome Measures
Name Time Method Number of participants with procedural success 3 months Resting left ventricle outflow tract gradients \< 30 mmHg, provoked left ventricle outflow tract gradients \< 50 mmHg, and mitral regurgitation (MR) ≤ grade 1+.
All-cause mortality 3 months Death from any cause during the observation period.
- Secondary Outcome Measures
Name Time Method Major adverse cardiovascular and cerebral events 3 months In-hospital mortality, atrioventricular block that need permanent pacemaker implantation, sternotomy conversion, iatrogenic ventricular septal perforation, iatrogenic valvular injury, imaging examination-validated cerebral complications.
Left ventricular outflow tract diameter 7 days and 3 months Left ventricular outflow tract diameter as measured by echocardiography.
Number of participants with device success 1 day Successful accession, delivery, and retrieval of the resection device, successful resection of the septal myocardium, resting left ventricle outflow tract gradient less than 50 mmHg and mitral regurgitation (MR) ≤ grade 2+ during operation after resection, and free from conversion to midline thoracotomy during operation.
Score of the Kansas City Cardiomyopathy Questionnaire 7 days and 3 months The score of the Kansas City Cardiomyopathy Questionnaire have a range 0-100. A higher score means better heart function.
Left atria volume 7 days and 3 months The left atria volume as measured by echocardiography.
New York Heart Association class 7 days and 3 months New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function.
Septal thickness 7 days and 3 months Basal and mid septal thickness as measured by echocardiography.
Left ventricle mass 7 days and 3 months Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.
6-minute walking test 3 months 6-minute walking test. A longer distance means better heart function.
Left ventricular outflow tract gradient 7 days and 3 months Left ventricular outflow tract gradient as measured by echocardiography.
Grade of mitral regurgitation 7 days and 3 months Grade of mitral regurgitation as measured by echocardiography, with a scale of 0, 1+, 2+, 3+, 4+. A higher grade means worse mitral regurgitaion.
Grade of systolic anterior motion 7 days and 3 months Grade of systolic anterior motion as measured by echocardiography, with a scale of 0, 1, 2, 3, 4. A higher grade means worse mitral regurgitaion.
Number of Participants with technical success 7 days or before discharge Resting left ventricle outflow tract gradients \< 30 mmHg without in-hospital death.
Trial Locations
- Locations (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China