Transapical Beating-heart Myectomy for the Treatment of Apical Hypertrophic Cardiomyopathy

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.

Official Title
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Transapical Beating-heart Myectomy in Patient With Apical Hypertrophic Cardiomyopathy: Safety and Efficacy Results of a Phase I Clinical Trial

Conditions
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Apical Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Device: Transapical beating-heart septal myectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were diagnosed as apical hypertrophic cardiomyopathy, with maximal apical 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. Exclusion Criteria: Patients who were pregnant. Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-chamber cardiac surgery. Patients who had severe heart failure with left ventricle ejection fraction < 40%. Patients whose estimated life expectancy < 12 months. 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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Beating-Heart Myectomy Device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Apical Hypertrophic Cardiomyopathy<br>Transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy | Device: Transapical beating-heart septal myectomy<br>* We have invented a beating-heart myectomy device. Using this device, myectomy could be performed in the beating heart via a mini-thoractomy approach. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. We are now conducting the study to explore the feasibility, the safety, and the efficacy of transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Death from any cause during the observation period. | 3 months | 
| Procedural success | Body surface area-indexed left ventricular end-diastolic volume increased by 10% compared with baseline as measured by echocardiography. A higher left ventricular end-diastolic volume indicates enlarged left ventricular chamber. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular end-diastolic pressure | Left ventricular end-diastolic pressure measure by hemodynamic catheterization. | 1 day | 
| Left ventricular end-systolic volume | Left ventricular end-diastolic volume as measured by echocardiography and indexed by body surface area. A higher left ventricular end-systolic volume indicates enlarged left ventricular chamber. | 7 days and 3 months | 
| Peak oxygen consumption | Peak oxygen consumption as measured by cardiopulmonary exercise testing. | 3 months | 
| Pulmonary artery wedge pressure | Pulmonary artery wedge pressure as measured by Swan-Ganz catheter. | 3 days | 
| Stroke volume | Stroke volume as measured by Swan-Ganz catheter. | 3 days | 
| Left ventricle mass | Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance. | 3 months | 
| Cardiac diastolic function | The ratio between early mitral inflow velocity and mitral annular early diastolic velocity ( E/e') as measured by transthoracic echocardiography. | 3 months | 
| Left atria volume | The left atria volume as measured by echocardiography. | 3 months | 
| Ventricular wall thickness | Ventricular wall thickness as measured by echocardiography. | 3 months | 
| Device success | Successful accession, delivery, and retrieval of the resection device, successful resection of the ventricular myocardium, and free from conversion to midline thoracotomy during operation. | 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. | 3 months | 
| 6-minute walking test | 6-minute walking test. A longer distance means better heart function. | 3 months | 
| Heart function-associated quality of life | Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function. | 3 months | 
| Major adverse cardiovascular and cerebral events | Procedure-related mortality and unplanned surgical procedures during hospitalization, permanent pacemaker implantation, iatrogenic valvular injury, imaging examination-validated cerebral complications. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midventricular obstruction and cavity obliteration, Apical Hypertrophic Cardiomyopathy, Septal Myectomy, Transapical Beating-heart Septal Myectomy, Minimally Invasive