Nonobstructive Hypertrophic CardiomyopathyNCT05648825
Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
A study testing Transapical beating-heart septal myectomy in people with Nonobstructive Hypertrophic Cardiomyopathy, run by Xiang Wei at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Nonobstructive Hypertrophic Cardiomyopathy
- What is being tested?
- Transapical beating-heart septal myectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2022to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who were diagnosed as nonobstructive hypertrophic cardiomyopathy, with maximal apical wall thickness ≥ 15 mm.
- Patients with heart function of New York Heart Association ≥ class II.
- Presenting with severe symptoms, e.g. angina, dyspnea, or fatigue, that were unresponsive or intolerant to pharmaceutical therapies;
- Kansas City Cardiomyopathy Questionnaire (KCCQ) score < 80;
- 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.
- 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.
Who cannot join
- Patients who were pregnant.
- Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-chamber cardiac surgery.
- Patients who had severe heart failure with left ventricle ejection fraction < 50%.
- Patients whose estimated life expectancy < 12 months.
- Patient who were non-compliant.
- peak VO2 of cardiopulmonary exercise test ≥ 90% of predicted.
- LVOT obstruction.
- 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 locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
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.
- Being tested
- Transapical beating-heart septal myectomy
- Keywords
- Septal Myectomy, Transapical Beating-heart Septal Myectomy, Minimally Invasive, Midventricular obstruction and cavity obliteration, Nonobstructive Hypertrophic Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Transapical beating-heart septal myectomy | Experimental | Transapical beating-heart myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy Receives: Device: Transapical beating-heart septal myectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 6 months
Secondary outcomes (23)
Left ventricular end-diastolic pressure
Left ventricular end-diastolic pressure measure by hemodynamic catheterization.
Measured: 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.
Measured: 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.
Measured: 7 days and 6 months
Obliteration
Rate of obliteration and ratio of obliteration to cavity as measured by TTE
Measured: 6 months
Peak oxygen consumption
Peak oxygen consumption as measured by cardiopulmonary exercise testing.
Measured: 6 months
pVO2
pVO2 as measured by cardiopulmonary exercise testing.
Measured: 6 months
Pulmonary artery wedge pressure
Pulmonary artery wedge pressure as measured by Swan-Ganz catheter.
Measured: 3 days
Stroke volume
Stroke volume as measured by Swan-Ganz catheter.
Measured: 3 days
Left ventricle mass
Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.
Measured: 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.
Measured: 6 months
Left atria volume
The left atria volume as measured by echocardiography.
Measured: 6 months
Ventricular wall thickness
Ventricular wall thickness as measured by echocardiography.
Measured: 6 months
LVOT gradient
Resting and provoked left ventricular outflow tract gradient as measured by echocardiography.
Measured: 1 week, 6 months
Midventricular gradient
Resting and provoked midventricular gradient as measured by echocardiography.
Measured: 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.
Measured: 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.
Measured: 6 months
6-minute walking test
6-minute walking test. A longer distance means better heart function.
Measured: 6 months
Heart function-associated quality of life
Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function.
Measured: 6 months
Angina level
Score of the Seattle angina questionnaire.
Measured: 6 months
NT-proBNP
Measured: N-terminal pro-brain natriuretic peptide
cTnI
cardiac troponin I
Measured: 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.
Measured: 6 months
All cause mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start15 Nov 2022
- Primary completion30 Jul 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nonobstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Beating-Heart Myectomy Device
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiang Wei, Tongji Hospital
- Investigators
- Xiang Wei, M.D., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648825
- Sponsor's protocol ID
- 2022-S086
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the conclusive participant data, after removing the individual information of privacy, will be uploaded as supporting information when publishing the current study.
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.
PubMed 31642911Schaff 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.
PubMed 20176208
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05648825
- Acronym / sponsor ID
- 2022-S086
- Keywords
- Septal Myectomy, Transapical Beating-heart Septal Myectomy, Minimally Invasive, Midventricular obstruction and cavity obliteration, Nonobstructive Hypertrophic Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiang WeiUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Beating-Heart Myectomy Device
| Arm | Type | Receives |
|---|---|---|
| Transapical beating-heart septal myectomy | Experimental | Device: Transapical beating-heart septal myectomyTransapical beating-heart myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who were diagnosed as nonobstructive hypertrophic cardiomyopathy, with maximal apical wall thickness ≥ 15 mm.
- Patients with heart function of New York Heart Association ≥ class II.
- Presenting with severe symptoms, e.g. angina, dyspnea, or fatigue, that were unresponsive or intolerant to pharmaceutical therapies;
- Kansas City Cardiomyopathy Questionnaire (KCCQ) score < 80;
- 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.
Key exclusion criteria (8 listed)
- Patients who were pregnant.
- Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-chamber cardiac surgery.
- Patients who had severe heart failure with left ventricle ejection fraction < 50%.
- Patients whose estimated life expectancy < 12 months.
- Patient who were non-compliant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transapical beating-heart septal myectomyWe 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. | Device | Transapical beating-heart septal myectomy |
Primary outcome
Procedural success
Time frame: 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) .
23 secondary outcomes
Left ventricular end-diastolic pressure
Time frame: 1 day
Left ventricular end-systolic volume
Time frame: 7 days and 6 months
Left ventricular end-diastolic volume
Time frame: 7 days and 6 months
Obliteration
Time frame: 6 months
Peak oxygen consumption
Time frame: 6 months
pVO2
Time frame: 6 months
Pulmonary artery wedge pressure
Time frame: 3 days
Stroke volume
Time frame: 3 days
Left ventricle mass
Time frame: 6 months
Cardiac diastolic function
Time frame: 6 months
Left atria volume
Time frame: 6 months
Ventricular wall thickness
Time frame: 6 months
LVOT gradient
Time frame: 1 week, 6 months
Midventricular gradient
Time frame: 1 week, 6 months
Device success
Time frame: 6 months
New York Heart Association class
Time frame: 6 months
6-minute walking test
Time frame: 6 months
Heart function-associated quality of life
Time frame: 6 months
Angina level
Time frame: 6 months
NT-proBNP
Time frame: N-terminal pro-brain natriuretic peptide
cTnI
Time frame: 1 week, 6 months
Major adverse cardiovascular and cerebral events
Time frame: 6 months
All cause mortality
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 31642911Fang 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.
- Background: PubMed 20176208Schaff 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.
- Individual participant dataSharing planned: Yes. All of the conclusive participant data, after removing the individual information of privacy, will be uploaded as supporting information when publishing the current study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiang Wei, M.D. study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transapical beating-heart septal myectomy in people with Nonobstructive Hypertrophic Cardiomyopathy, run by Xiang Wei at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05648825, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.