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Hypertrophic Obstructive CardiomyopathyNCT05957419

Transapical Beating-Heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study

A study testing Transapical beating-heart septal myectomy in people with Hypertrophic Obstructive Cardiomyopathy, run by Xiang Wei at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 hypertrophic obstructive cardiomyopathy. This is a prospective, single-arm, multi-center study. Read more about this study

Who is it for?
Ages 8 to 80 years
Conditions the study is for
Hypertrophic Obstructive 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
1,000 participants
Where
1 siteChina
Study dates
Jul 2023to Oct 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 resting or provoked left ventricular outflow tract gradient > 50 mmHg, and 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

  • 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

    Recruiting

Other trials in China

About this study

Official title: Minimally Invasive Transapical Septal Myectomy in the Beating Hearts for the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study

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 hypertrophic obstructive cardiomyopathy. This is a prospective, single-arm, multi-center study.

Read the detailed description

Surgical septal myectomy remains the gold standard for the treatment of hypertrophic obstructive cardiomyopathy. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient relieve the obstruction of the left ventricle outflow tract while guarantee safety. To increase the visualization and minimize the surgical injury of conventional septal myectomy, the investigators 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 ventricle outflow tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor sufficient relief of left ventricle outflow tract obstruction and mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, participants is 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
Hypertrophic Obstructive Cardiomyopathy, Septal Myectomy, Systolic Anterior Motion, Left Ventricle Outflow Tract Obstruction, Mitral Regurgitation, Transapical, Off-pump, Minimally invasive
Medical subject headings
Cardiomyopathy, Hypertrophic, 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 ventricle outlet tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor the muscular resection for sufficient relief of left ventricle outlet tract obstruction and mitral regurgitation, while preventing iatrogenic injuries.

Study groups in NCT05957419
Study groupRoleWhat they receive
Hypertrophic Obstructive CardiomyopathyExperimentalTransapical beating-heart septal myectomy for the patient with hypertrophic obstructive cardiomyopathy.
Receives: Procedure: Transapical beating-heart septal myectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Death from any cause during the observation period.

    Measured: 3 months

  2. Number of participants with procedural success

    Resting left ventricle outflow tract gradients < 30 mmHg, provoked left ventricle outflow tract gradients < 50 mmHg, and mitral regurgitation (MR) ≤ grade 1+.

    Measured: 3 months

Secondary outcomes (13)

  1. Number of participants with device success

    Successful accession, delivery, and retrieval of the resection device, successful resection of the septal myocardium, resting left ventricle outflow tract gradient less than 50 mmHg and mitral regurgitation (MR) ≤ grade 2+ during operation after resection, and free from conversion to midline thoracotomy during operation.

    Measured: 1 day

  2. Septal thickness

    Basal and mid septal thickness as measured by echocardiography.

    Measured: 7 days and 3 months

  3. 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

  4. Left atria volume

    The left atria volume as measured by echocardiography.

    Measured: 7 days and 3 months

  5. 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

  6. 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

  7. 6-minute walking test

    6-minute walking test. A longer distance means better heart function.

    Measured: 3 months

  8. Score of the Kansas City Cardiomyopathy Questionnaire

    The score of the Kansas City Cardiomyopathy Questionnaire have a range 0-100. A higher score means better heart function.

    Measured: 7 days and 3 months

  9. Left ventricular outflow tract gradient

    Left ventricular outflow tract gradient as measured by echocardiography.

    Measured: 7 days and 3 months

  10. Grade of mitral regurgitation

    Grade of mitral regurgitation as measured by echocardiography, with a scale of 0, 1+, 2+, 3+, 4+. A higher grade means worse mitral regurgitaion.

    Measured: 7 days and 3 months

  11. Left ventricular outflow tract diameter

    Left ventricular outflow tract diameter as measured by echocardiography.

    Measured: 7 days and 3 months

  12. Number of Participants with technical success

    Resting left ventricle outflow tract gradients < 30 mmHg without in-hospital death.

    Measured: 7 days or before discharge

  13. Grade of systolic anterior motion

    Grade of systolic anterior motion as measured by echocardiography, with a scale of 0, 1, 2, 3, 4. A higher grade means worse mitral regurgitaion.

    Measured: 7 days and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2023
  2. Study startJul 2023 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

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
Single Group Assignment Beating-heart myectomy device
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05957419
Sponsor's protocol ID
2023-S011
Status last verified
Jul 2023
First submitted
6 Jul 2023
Last updated
24 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

Questions about this trial

What is this clinical trial studying?

A study testing Transapical beating-heart septal myectomy in people with Hypertrophic Obstructive 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 24 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?

Each site lists its own contact: choose the nearest one under Trial locations. 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 NCT05957419, 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 24 Jul 2023.

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