Clinical trial NCT05332691: Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertrophic Obstructive Cardiomyopathy
Keywords: Hypertrophic Obstructive Cardiomyopathy
Septal Myectomy
Systolic Anterior Motion
Left Ventricle Outflow Tract Obstruction
Mitral Regurgitation
Transapical
Off-pump
Minimally invasive
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Beating-heart myectomy device
Primary purpose: TREATMENT

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, single-center, first-in-man 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, 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.

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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 3 months
measure: Procedural success
timeFrame: 3 months
Secondary outcomes:
measure: Device success
timeFrame: 1 day
measure: Septal thickness
timeFrame: 7 days and 3 months
measure: Left ventricle mass
timeFrame: 3 months
measure: Left ventricle volume
timeFrame: 7 days and 3 months
measure: Cardiac diastolic function
timeFrame: 7 days and 3 months
measure: Left atria volume
timeFrame: 7 days and 3 months
measure: Major adverse cardiovascular and cerebral events
timeFrame: 3 months
measure: New York Heart Association class
timeFrame: 7 days and 3 months
measure: 6-minute walking test
timeFrame: 3 months
measure: Heart function-associated quality of life
timeFrame: 7 days and 3 months
measure: Left ventricular outflow tract gradient
timeFrame: 7 days and 3 months
measure: Evaluation of the mitral valve
timeFrame: 7 days and 3 months
measure: Left ventricular outflow tract diameter
timeFrame: 7 days and 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xiang Wei, M.D.
role: STUDY_CHAIR
References:
citation: Fang J, Wang R, Liu H, Su Y, Chen J, Han X, Wei Y, Chen Y, Cheng L, Wei X. Transapical septal myectomy in the beating heart via a minimally invasive approach: a feasibility study in swine. Interact Cardiovasc Thorac Surg. 2020 Feb 1;30(2):303-311. doi: 10.1093/icvts/ivz249.