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Evaluating the effect and influencing factors of transapical beating-heart septal myectomy (TA-BSM) for hypertrophic obstructive cardiomyopathy patients with mitral valve insufficiency by echocardiography

Evaluating the effect and influencing factors of transapical beating-heart septal myectomy (TA-BSM) for hypertrophic obstructive cardiomyopathy patients with mitral valve insufficiency by echocardiography

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070982
Enrollment
Unknown
Registered
2023-04-27
Start date
2023-05-08
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy(HCM)

Interventions

Patients with transapical beating-heart septal myectomy:N/A

Sponsors

Department of Ultrasound Imaging, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age ?18 years old; 2.Patients who were diagnosed as hypertrophic obstructive cardiomyopathy (HOCM) with mitral regurgitation (MR) ?2+ and underwent transcapical septal resection (TA-BSM) were enrolled; 3.The maximum thickness of interventricular septum =15mm; 4.LVOTG=50mmHg measured by transthoracic echocardiography in resting state or stimulated state; 5.Obvious clinical symptoms, poor effect after adequate drug treatment or unable to tolerate adverse drug reactions; 6.New York Heart Association (NYHA) functional class =II; 7.Voluntary informed consent.

Exclusion criteria

Exclusion criteria: 1.Non-obstructive hypertrophic cardiomyopathy; 2.Complicated with other cardiac diseases requiring surgical treatment (e.g., coronary artery surgery); 3.Patients with previous history of mitral valve surgery, aortic valve surgery, previous ventricular septal resection; 4.Organic mitral valve structural abnormality; 5.Heart failure, left ventricular ejection fraction <40%; 6.Pregnant and lactating patients; 7.Patients with life expectancy less than 12 months; 8.Patients have participated in other drug/medical device clinical trials within 3 months; 9.Severe liver failure 10.Cerebrovascular accident within 3 months; 11.Acute gastrointestinal ulcer or upper gastrointestinal bleeding within 3 months; 12.The researchers judged that the subjects had poor compliance and could not complete the study according to the requirements. 13.Are receiving other treatments that may affect cardiac function (e.g., adjuvant radiotherapy, chemotherapy); 14.Patients with poor echocardiographic image quality;

Design outcomes

Primary

MeasureTime frame
Effective regurgitant orifice area(EROA,cm2);Regurgitant volume(RVol,ml);Regurgitant fraction(RF,%);Left ventricular outflow tract pressure difference(LVOTG,mmHg);

Secondary

MeasureTime frame
Anterior mitral valve length(AML,mm);Posterior mitral valve length(PML,mm);Mitral annular area(mm2);Annulus circumference of mitral valve(Annulus Perimeter,mm);Anteroposterior diameter of mitral annulus(A-P Diameter,mm);Mitral annular commissure diameter(mm);Mitral annular height(mm);Mitral tenting height(mm);Mitral tenting volume(ml);Aortomitral angle (°);Area of the anterior leaflet of the mitral valve,mm2;Area of the posterior mitral leaflet,mm2;Mitral valve coaptation height,mm;Residual length of the anterior mitral leaflet;

Countries

China

Contacts

Public ContactYani Liu

Department of Medical Ultrasound, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

yani.liu@163.com+86 13886062141

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026