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| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
| Fudan University | OTHER |
| Second Hospital of Jilin University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertrophic Obstructive Cardiomyopathy | Experimental | Transapical beating-heart septal myectomy for the patient with hypertrophic obstructive cardiomyopathy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transapical beating-heart septal myectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Death from any cause during the observation period. | 3 months |
| 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+. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31642911 | Result | 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. |
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All of the conclusive participant data, after removing the individual information of privacy, will be uploaded as supporting information when publishing the current study
After the current study is published.
All readers who were interested in the current study.
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| OTHER |
Single Group Assignment Beating-heart myectomy device
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| Septal thickness | Basal and mid septal thickness as measured by echocardiography. | 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. | 7 days and 3 months |
| Left atria volume | The left atria volume as measured by echocardiography. | 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. | 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. | 7 days and 3 months |
| 6-minute walking test | 6-minute walking test. A longer distance means better heart function. | 3 months |
| 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. | 7 days and 3 months |
| Left ventricular outflow tract gradient | Left ventricular outflow tract gradient as measured by echocardiography. | 7 days and 3 months |
| 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. | 7 days and 3 months |
| Left ventricular outflow tract diameter | Left ventricular outflow tract diameter as measured by echocardiography. | 7 days and 3 months |
| Number of Participants with technical success | Resting left ventricle outflow tract gradients < 30 mmHg without in-hospital death. | 7 days or before discharge |
| 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. | 7 days and 3 months |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |