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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 myectomy for the treatment of apical hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transapical beating-heart septal myectomy | Experimental | Transapical beating-heart myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transapical beating-heart septal myectomy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) . | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular end-diastolic pressure | Left ventricular end-diastolic pressure measure by hemodynamic catheterization. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiang Wei, M.D. | Tongji Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31642911 | Background | 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. | |
| 20176208 | Background | Schaff 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. |
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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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Beating-Heart Myectomy Device
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| 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. | 7 days and 6 months |
| Obliteration | Rate of obliteration and ratio of obliteration to cavity as measured by TTE | 6 months |
| Peak oxygen consumption | Peak oxygen consumption as measured by cardiopulmonary exercise testing. | 6 months |
| pVO2 | pVO2 as measured by cardiopulmonary exercise testing. | 6 months |
| Pulmonary artery wedge pressure | Pulmonary artery wedge pressure as measured by Swan-Ganz catheter. | 3 days |
| Stroke volume | Stroke volume as measured by Swan-Ganz catheter. | 3 days |
| Left ventricle mass | Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance. | 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. | 6 months |
| Left atria volume | The left atria volume as measured by echocardiography. | 6 months |
| Ventricular wall thickness | Ventricular wall thickness as measured by echocardiography. | 6 months |
| LVOT gradient | Resting and provoked left ventricular outflow tract gradient as measured by echocardiography. | 1 week, 6 months |
| Midventricular gradient | Resting and provoked midventricular gradient as measured by echocardiography. | 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. | 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. | 6 months |
| 6-minute walking test | 6-minute walking test. A longer distance means better heart function. | 6 months |
| Heart function-associated quality of life | Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function. | 6 months |
| Angina level | Score of the Seattle angina questionnaire. | 6 months |
| NT-proBNP | N-terminal pro-brain natriuretic peptide |
| cTnI | cardiac troponin I | 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. | 6 months |
| All cause mortality | 6 months |