Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy

Xiang Wei

Status: Active, not recruiting

Conditions: Nonobstructive Hypertrophic Cardiomyopathy

Treatments: Device: Transapical beating-heart septal myectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05648825

2022-S086

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Transapical beating-heart septal myectomy

Experimental group

Description:

Transapical beating-heart myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy

Treatment:

Device: Transapical beating-heart septal myectomy