Nonobstructive Hypertrophic CardiomyopathyNCT05952154
Transapical Beating-Heart Septal Myectomy in Patients With 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 septal myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Nonobstructive Hypertrophic Cardiomyopathy
- What is being tested?
- Transapical beating-heart septal myectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients whose maximal ventricular septal wall thickness ≥ 15 mm.
- Patients with heart function of New York Heart Association ≥ class II.
- Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
- 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-heart surgery.
- Patients who had severe heart failure with left ventricle ejection fraction < 40%.
- Patients whose estimated life expectancy < 12 m.
- Patient who were non-compliant.
- 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, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Xiang Wei, M.D., +8613995525956, xiangwei@tjh.tjmu.edu.cn
Jing Fang, M.D., +8613296640596, jingfang@hust.edu.cn
About this study
Official title: Minimally Invasive Transapical Beating-Heart Septal Myectomy in Patients With Nonobstructive Hypertrophic Cardiomyopathy
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.
Read the detailed description
Medical therapy is first recommended for patients with nonobstructive hypertrophic cardiomyopathy administrated at onset of heart failure symptoms. As the disease progresses, patients with global ejection fraction < 50% should be evaluated with respect to eligibility and motivation for heart transplant. However, for those with preserved ejection fraction and drug-refractory heart failure symptoms, there is still no optimal therapy. Some patients with increased left atrial volume and/or diastolic dysfunction can be recognized as a result of excessive myocardial hypertrophy, and the septal resection for these patients may be beneficial. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient resection of hypertrophied septal myocardium while guarantee safety. To increase the visualization and minimize the surgical injury of conventional septal myectomy, we have invented a novel beating-heart myectomy device. Through a mini-thoractomy, septal myectomy could be accomplished via a transapical access in the beating heart using the beating-heart myectomy device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricular morphology and hemodynamics are evaluated each time after resection. Multiple resections are performed to tailor sufficient enlargement of left ventricular end-diastolic volume and improvement of mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, patients are scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.
- Being tested
- Transapical beating-heart septal myectomy
- Keywords
- Nonobstructive Hypertrophic Cardiomyopathy, Septal Myectomy, Mitral Regurgitation, Transapical, Off-pump, Minimally invasive
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transapical beating-heart septal myectomyProcedure or surgery
Also called Minimally invasive transapical septal myectomy in the beating hearts
We have invented a beating-heart myectomy device.Through a minimally invasive intercostal incision, septal myectomy could be accomplished via a transapical access in the beating heart using the device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricular end-diastolic volume and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor the muscular resection for sufficient enlargement of left ventricular end-diastolic volume and improvement of mitral regurgitation, while preventing iatrogenic injuries.
| Study group | Role | What they receive |
|---|---|---|
| Nonbstructive Hypertrophic Cardiomyopathy | Experimental | Transapical beating-heart septal myectomy for the patient with nonobstructive hypertrophic cardiomyopathy and Heart Failure. Receives: Procedure: Transapical beating-heart septal myectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death from any cause during the observation period.
Measured: 3 months
Procedural success
A reduction of ≥1 New York Heart Association (NYHA) class and a decrease of ≥ 20% of left atrial volume
Measured: 3 months
Secondary outcomes (11)
Device success
Successful accession, delivery, and retrieval of the resection device, successful resection of the septal myocardium, mitral regurgitation (MR) ≤ grade 2+ during operation after resection, and free from conversion to midline thoracotomy during operation.
Measured: 1 day
Septal thickness
Basal and mid septal thickness as measured by echocardiography.
Measured: 7 days and 3 months
Left ventricle mass
Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.
Measured: 7 days and 3 months
Left atrial volume
The left atria volume as measured by echocardiography.
Measured: 7 days and 3 months
Major adverse cardiovascular and cerebral events
In-hospital mortality, atrioventricular block that need permanent pacemaker implantation, sternotomy conversion, iatrogenic ventricular septal perforation, iatrogenic valvular injury, imaging examination-validated cerebral complications.
Measured: 3 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: 7 days and 3 months
6-minute walking test
6-minute walking test. A longer distance means better heart function.
Measured: 3 months
Heart function-associated quality of life
Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function.
Measured: 7 days and 3 months
Evaluation of the mitral valve
Grade of mitral regurgitation and systolic anterior motion as measured by echocardiography.
Measured: 7 days and 3 months
Left ventricular outflow tract diameter
Left ventricular outflow tract diameter as measured by echocardiography.
Measured: 7 days and 3 months
Left ventricular end-diastolic volume
Left ventricular end-diastolic volume as measured by cardiac magnetic resonance.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Experimental Group: 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952154
- Sponsor's protocol ID
- 2023-S015
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 31642911
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Transapical Beating-Heart Septal Myectomy in Patients With Nonobstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05952154
- Acronym / sponsor ID
- 2023-S015
- Keywords
- Nonobstructive Hypertrophic Cardiomyopathy, Septal Myectomy, Mitral Regurgitation, Transapical, Off-pump, Minimally invasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiang WeiUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Jul 2023 (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 septal myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.
Detailed description
Medical therapy is first recommended for patients with nonobstructive hypertrophic cardiomyopathy administrated at onset of heart failure symptoms. As the disease progresses, patients with global ejection fraction < 50% should be evaluated with respect to eligibility and motivation for heart transplant. However, for those with preserved ejection fraction and drug-refractory heart failure symptoms, there is still no optimal therapy. Some patients with increased left atrial volume and/or diastolic dysfunction can be recognized as a result of excessive myocardial hypertrophy, and the septal resection for these patients may be beneficial. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient resection of hypertrophied septal myocardium while guarantee safety. To increase the visualization and minimize the surgical injury of conventional septal myectomy, we have invented a novel beating-heart myectomy device. Through a mini-thoractomy, septal myectomy could be accomplished via a transapical access in the beating heart using the beating-heart myectomy device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricular morphology and hemodynamics are evaluated each time after resection. Multiple resections are performed to tailor sufficient enlargement of left ventricular end-diastolic volume and improvement of mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, patients are scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental Group: Beating-heart myectomy device
| Arm | Type | Receives |
|---|---|---|
| Nonbstructive Hypertrophic Cardiomyopathy | Experimental | Procedure: Transapical beating-heart septal myectomyTransapical beating-heart septal myectomy for the patient with nonobstructive hypertrophic cardiomyopathy and Heart Failure. |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients whose maximal ventricular septal wall thickness ≥ 15 mm.
- Patients with heart function of New York Heart Association ≥ class II.
- Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
- 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
Key exclusion criteria (6 listed)
- Patients who were pregnant.
- Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
- Patients who had severe heart failure with left ventricle ejection fraction < 40%.
- Patients whose estimated life expectancy < 12 m.
- 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 myectomyAlso: Minimally invasive transapical septal myectomy in the beating heartsWe have invented a beating-heart myectomy device.Through a minimally invasive intercostal incision, septal myectomy could be accomplished via a transapical access in the beating heart using the device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricular end-diastolic volume and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor the muscular resection for sufficient enlargement of left ventricular end-diastolic volume and improvement of mitral regurgitation, while preventing iatrogenic injuries. | Procedure or surgery | Nonbstructive Hypertrophic Cardiomyopathy |
Primary outcome
All-cause mortality
Time frame: 3 months
Death from any cause during the observation period.
Procedural success
Time frame: 3 months
A reduction of ≥1 New York Heart Association (NYHA) class and a decrease of ≥ 20% of left atrial volume
11 secondary outcomes
Device success
Time frame: 1 day
Septal thickness
Time frame: 7 days and 3 months
Left ventricle mass
Time frame: 7 days and 3 months
Left atrial volume
Time frame: 7 days and 3 months
Major adverse cardiovascular and cerebral events
Time frame: 3 months
New York Heart Association class
Time frame: 7 days and 3 months
6-minute walking test
Time frame: 3 months
Heart function-associated quality of life
Time frame: 7 days and 3 months
Evaluation of the mitral valve
Time frame: 7 days and 3 months
Left ventricular outflow tract diameter
Time frame: 7 days and 3 months
Left ventricular end-diastolic volume
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- 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.
- 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.
Related trials for Nonobstructive Hypertrophic Cardiomyopathy
RecruitingPhase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTX-001
Nonobstructive Hypertrophic Cardiomyopathy
Not yet recruitingPhase 4
Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Nonobstructive Hypertrophic Cardiomyopathy
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
Enrolling by invitationPhase 2/3
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Symptomatic Hypertrophic Cardiomyopathy (HCM)
Not yet recruiting
Coronary Sinus Reducer Objective Impact on SymptoMs, Ischaemia and miCrovascular Resistance in Non-obstructive Hypertrophic CardioMyopathy
Hypertrophic Cardiomyopathy
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.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Wei, M.D. (+8613995525956, xiangwei@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT05952154, which also lists 1 linked publication.
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 19 Jul 2023.