Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy

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 Overview

• Status: Active, not recruiting
• Conditions: Nonobstructive Hypertrophic Cardiomyopathy
• Intervention / Treatment: Device: Transapical beating-heart septal myectomy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transapical beating-heart septal myectomy; Transapical beating-heart myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy

Device: Transapical beating-heart septal myectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) .	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality		6 months
Left ventricular end-diastolic pressure	Left ventricular end-diastolic pressure measure by hemodynamic catheterization.	1 day
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 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.	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.	7 days and 6 months
Obliteration	Rate of obliteration and ratio of obliteration to cavity as measured by TTE	6 months
Peak oxygen consumption	Peak oxygen consumption as measured by cardiopulmonary exercise testing.	6 months
pVO2	pVO2 as measured by cardiopulmonary exercise testing.	6 months
Left ventricle mass	Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.	6 months
Cardiac diastolic function	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.	6 months
Left atria volume	The left atria volume as measured by echocardiography.	6 months
Ventricular wall thickness	Ventricular wall thickness as measured by echocardiography.	6 months
LVOT gradient	Resting and provoked left ventricular outflow tract gradient as measured by echocardiography.	1 week, 6 months
Midventricular gradient	Resting and provoked midventricular gradient as measured by echocardiography.	1 week, 6 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.	6 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.	6 months
6-minute walking test	6-minute walking test. A longer distance means better heart function.	6 months
Heart function-associated quality of life	Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function.	6 months
Angina level	Score of the Seattle angina questionnaire.	6 months
NT-proBNP		N-terminal pro-brain natriuretic peptide
cTnI	cardiac troponin I	1 week, 6 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.	6 months

Collaborators and Investigators

• Sponsor: Xiang Wei
• Investigators: Study Chair: Xiang Wei, M.D., Tongji Hospital

Publications and helpful links

General Publications

• Fang J, Wang R, Liu H, Su Y, Chen J, Han X, Wei Y, Chen Y, Cheng L, Wei X. Transapical septal myectomy in the beating heart via a minimally invasive approach: a feasibility study in swine. Interact Cardiovasc Thorac Surg. 2020 Feb 1;30(2):303-311. doi: 10.1093/icvts/ivz249.
• Schaff HV, Brown ML, Dearani JA, Abel MD, Ommen SR, Sorajja P, Tajik AJ, Nishimura RA. Apical myectomy: a new surgical technique for management of severely symptomatic patients with apical hypertrophic cardiomyopathy. J Thorac Cardiovasc Surg. 2010 Mar;139(3):634-40. doi: 10.1016/j.jtcvs.2009.07.079.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): July 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Septal Myectomy; Minimally Invasive; Transapical Beating-heart Septal Myectomy; Midventricular obstruction and cavity obliteration; Nonobstructive Hypertrophic Cardiomyopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies; Cardiomegaly; Hypertrophy, Left Ventricular; Cardiomyopathy, Hypertrophic; Apical Hypertrophic Cardiomyopathy
• Other Study ID Numbers: 2022-S086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the conclusive participant data, after removing the individual information of privacy, will be uploaded as supporting information when publishing the current study.
• IPD Sharing Time Frame: After the current study is published.
• IPD Sharing Access Criteria: All readers who were interested in the current study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No