Clinical trial NCT05952154: Transapical Beating-Heart Septal Myectomy in Patients With Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
Official title: Minimally Invasive Transapical Beating-Heart Septal Myectomy in Patients With Nonobstructive Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nonobstructive Hypertrophic Cardiomyopathy
Keywords: Nonobstructive Hypertrophic Cardiomyopathy
Septal Myectomy
Mitral Regurgitation
Transapical
Off-pump
Minimally invasive
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Experimental Group: 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 nonobstructive hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.

Detailed description: Medical therapy is first recommended for patients with nonobstructive hypertrophic cardiomyopathy administrated at onset of heart failure symptoms. As the disease progresses, patients with global ejection fraction \< 50% should be evaluated with respect to eligibility and motivation for heart transplant. However, for those with preserved ejection fraction and drug-refractory heart failure symptoms, there is still no optimal therapy. Some patients with increased left atrial volume and/or diastolic dysfunction can be recognized as a result of excessive myocardial hypertrophy, and the septal resection for these patients may be beneficial. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient resection of hypertrophied septal myocardium 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 ventricular morphology and hemodynamics are evaluated each time after resection. Multiple resections are performed to tailor sufficient enlargement of left ventricular end-diastolic volume and improvement of mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, patients are 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 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: 7 days and 3 months
measure: Left atrial 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: Evaluation of the mitral valve
timeFrame: 7 days and 3 months
measure: Left ventricular outflow tract diameter
timeFrame: 7 days and 3 months
measure: Left ventricular end-diastolic volume
timeFrame: 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:
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.