Transapical Beating-Heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study

Xiang Wei1,000 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Hypertrophic Obstructive Cardiomyopathy

Interventions

Transapical beating-heart septal myectomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

All-cause mortality

Death from any cause during the observation period.

Time frame: 3 months

Number of participants with 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

Secondary Outcomes

Number of participants with 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: 7 days and 3 months

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.

Data from ClinicalTrials.gov

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