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, single-center, first-in-man study.
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, we 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, patients is scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
We have invented a beating-heart myectomy device.Through a minimally invasive intercostal incision, septal myectomy could be accomplished via a transapical access in the beating heart using the device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricle outlet tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor the muscular resection for sufficient relief of left ventricle outlet tract obstruction and mitral regurgitation, while preventing iatrogenic injuries.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGAll-cause mortality
Death from any cause during the observation period.
Time frame: 3 months
Procedural success
Resting left ventricle outflow tract gradients \< 30 mmHg, provoked left ventricle outflow tract gradients \< 50 mmHg, and mitral regurgitation (MR) ≤ grade 1+.
Time frame: 3 months
Device success
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.
Time frame: 1 day
Septal thickness
Basal and mid septal thickness as measured by echocardiography.
Time frame: 7 days and 3 months
Left ventricle mass
Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.
Time frame: 3 months
Left ventricle volume
Left ventricle end-diastolic volume as measured by echocardiography.
Time frame: 7 days and 3 months
Cardiac diastolic function
The ratio between early mitral inflow velocity and mitral annular early diastolic velocity ( E/e') as measured by echocardiography.
Time frame: 7 days and 3 months
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Left atria volume
The left atria volume as measured by echocardiography.
Time frame: 7 days and 3 months
Major adverse cardiovascular and cerebral events
In-hospital mortality, atrioventricular block that need permanent pacemaker implantation, sternotomy conversion, iatrogenic ventricular septal perforation, iatrogenic valvular injury, imaging examination-validated cerebral complications.
Time frame: 3 months
New York Heart Association class
New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function.
Time frame: 7 days and 3 months
6-minute walking test
6-minute walking test. A longer distance means better heart function.
Time frame: 3 months
Heart function-associated quality of life
Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function.
Time frame: 7 days and 3 months
Left ventricular outflow tract gradient
Left ventricular outflow tract gradient as measured by echocardiography.
Time frame: 7 days and 3 months
Evaluation of the mitral valve
Grade of mitral regurgitation and systolic anterior motion as measured by echocardiography.
Time frame: 7 days and 3 months
Left ventricular outflow tract diameter
Left ventricular outflow tract diameter as measured by echocardiography.
Time frame: 7 days and 3 months