Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy

N/AActive Not RecruitingNCT05648825

Xiang Wei100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Nonobstructive Hypertrophic Cardiomyopathy

Interventions

Transapical beating-heart septal myectomyDEVICE

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 nonobstructive hypertrophic cardiomyopathy.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who were diagnosed as nonobstructive hypertrophic cardiomyopathy, with maximal apical wall thickness ≥ 15 mm. 2. Patients with heart function of New York Heart Association ≥ class II. 3. Presenting with severe symptoms, e.g. angina, dyspnea, or fatigue, that were unresponsive or intolerant to pharmaceutical therapies; 4. Kansas City Cardiomyopathy Questionnaire (KCCQ) score \< 80; 5. Presenting with one of the following conditions: midventricular obstruction with gradient ≥ 50 mmHg; grade II or higher diastolic dysfunction; apical aneurysm; ventricular tachycardia that needed an ICD implantation; pulmonary hypertension. 6. 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-chamber cardiac surgery. 3. Patients who had severe heart failure with left ventricle ejection fraction \< 50%. 4. Patients whose estimated life expectancy \< 12 months. 5. Patient who were non-compliant. 6. peak VO2 of cardiopulmonary exercise test ≥ 90% of predicted. 7. LVOT obstruction. 8. 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

Outcomes

Primary Outcomes

Procedural success

Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement of ≥10 points, New York Heart Association (NYHA) improvement ≥ 1 grade, stroke volume increased by ≥10 mL, and diastolic function grading at normal or grade I (of III) .

Time frame: 6 months

Secondary Outcomes

Left ventricular end-diastolic pressure

Left ventricular end-diastolic pressure measure by hemodynamic catheterization.

Time frame: 1 day

Left ventricular end-systolic volume

Left ventricular end-systolic volume and indexed by body surface area. A higher left ventricular end-systolic volume indicates enlarged left ventricular chamber.

Time frame: 7 days and 6 months

Left ventricular end-diastolic volume

Left ventricular end-diastolic volume and indexed by body surface area. A higher left ventricular end-diastolic volume indicates enlarged left ventricular chamber.

Time frame: 7 days and 6 months

Obliteration

Rate of obliteration and ratio of obliteration to cavity as measured by TTE

Time frame: 6 months

Peak oxygen consumption

Peak oxygen consumption as measured by cardiopulmonary exercise testing.

Time frame: 6 months

pVO2

pVO2 as measured by cardiopulmonary exercise testing.

Time frame: 6 months

Pulmonary artery wedge pressure

Data from ClinicalTrials.gov

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