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

Not Applicable

Active, not recruiting

• Conditions: Apical Hypertrophic Cardiomyopathy

• 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
• Primary Completion: 2025-07-30
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-17
• Last Update Posted: 2025-09-23
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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. 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 < 70;
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Procedural success	6 months	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) .

Secondary Outcome Measures

Name	Time	Method
cTnI	1 week, 6 months	cardiac troponin I
Left ventricular end-diastolic pressure	1 day	Left ventricular end-diastolic pressure measure by hemodynamic catheterization.
Left ventricular end-systolic volume	7 days and 6 months	Left ventricular end-systolic volume and indexed by body surface area. A higher left ventricular end-systolic volume indicates enlarged left ventricular chamber.
Left ventricular end-diastolic volume	7 days and 6 months	Left ventricular end-diastolic volume and indexed by body surface area. A higher left ventricular end-diastolic volume indicates enlarged left ventricular chamber.
Obliteration	6 months	Rate of obliteration and ratio of obliteration to cavity as measured by TTE
Peak oxygen consumption	6 months	Peak oxygen consumption as measured by cardiopulmonary exercise testing.
pVO2	6 months	pVO2 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.
Left ventricle mass	6 months	Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.
Cardiac diastolic function	6 months	The ratio between early mitral inflow velocity and mitral annular early diastolic velocity ( E/e') and ratio between early mitral inflow velocity and late mitral inflow velocity (E/A) as measured by transthoracic echocardiography.
Left atria volume	6 months	The left atria volume as measured by echocardiography.
Ventricular wall thickness	6 months	Ventricular wall thickness as measured by echocardiography.
LVOT gradient	1 week, 6 months	Resting and provoked left ventricular outflow tract gradient as measured by echocardiography.
Midventricular gradient	1 week, 6 months	Resting and provoked midventricular gradient as measured by echocardiography.
Device success	6 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.
New York Heart Association class	6 months	New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function.
6-minute walking test	6 months	6-minute walking test. A longer distance means better heart function.
Heart function-associated quality of life	6 months	Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function.
Angina level	6 months	Score of the Seattle angina questionnaire.
NT-proBNP	N-terminal pro-brain natriuretic peptide
Major adverse cardiovascular and cerebral events	6 months	Procedure-related mortality and unplanned surgical procedures during hospitalization, permanent pacemaker implantation, iatrogenic valvular injury, imaging examination-validated cerebral complications.
All cause mortality	6 months

Trial Locations

Locations (1)

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