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

Not Applicable

Recruiting

• Conditions: Apical Hypertrophic Cardiomyopathy
• Interventions: Device: Transapical beating-heart septal myectomy

• Registration Number: NCT05648825
• Lead Sponsor: Xiang Wei

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-15
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-05-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients who were diagnosed as apical hypertrophic cardiomyopathy, with maximal apical 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-chamber cardiac surgery.
3. Patients who had severe heart failure with left ventricle ejection fraction < 40%.
4. Patients whose estimated life expectancy < 12 months.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Apical Hypertrophic Cardiomyopathy	Transapical beating-heart septal myectomy	Transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy

Primary Outcome Measures

Name	Time	Method
All-cause mortality	3 months	Death from any cause during the observation period.
Procedural success	3 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China