aortic valve
Conditions
Interventions
Sponsors
Union Hospital,Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients with New York Heart Association (NYHA) grade II and above, meet the first standard Patients with New York Heart Association (NYHA) grade I, meet the first and second. 1. meet one of the following conditions Pulmonary valve regurgitation score = 30% measured by Cardiac magnetic resonance imaging (MRI); Moderate (3+) to severe (4+) pulmonary arterial valves regurgitation measured by transthoracic ultrasonography; 2. Patients with New York Heart Association (NYHA) grade I should meet one of the following conditions Right ventricular end-diastolic volume index (RVEDVI) = 150 ml/m2 measured by cardiac magnetic resonance imaging (MRI); Right ventricular end-diastolic volume (RVEDV) and left ventricular end-diastolic volume (LVEDV) ratio = 2.0 measured by cardiac magnetic resonance imaging (MRI).;Inclusion criteria: Patients with New York Heart Association (NYHA) grade II and above, meet the first standard Patients with New York Heart Association (NYHA) grade I, meet the first and second. 1. meet one of the following conditions Pulmonary valve regurgitation score = 30% measured by Cardiac magnetic resonance imaging (MRI); Moderate (3+) to severe (4+) pulmonary arterial valves regurgitation measured by transthoracic ultrasonography; 2. Patients with New York Heart Association (NYHA) grade I should meet one of the following conditions Right ventricular end-diastolic volume index (RVEDVI) = 150 ml/m2 measured by cardiac magnetic resonance imaging (MRI); Right ventricular end-diastolic volume (RVEDV) and left ventricular end-diastolic volume (LVEDV) ratio = 2.0 measured by cardiac magnetic resonance imaging (MRI).;Inclusion criteria: Patients with New York Heart Association (NYHA) grade II and above, meet the first standard Patients with New York Heart Association (NYHA) grade I, meet the first and second. 1. meet one of the following conditions Pulmonary valve regurgitation score = 30% measured by Cardiac magnetic resonance imaging (MRI); Moderate (3+) to severe (4+) pulmonary arterial valves regurgitation measured by transthoracic ultrasonography; 2. Patients with New York Heart Association (NYHA) grade I should meet one of the following conditions Right ventricular end-diastolic volume index (RVEDVI) = 150 ml/m2 measured by cardiac magnetic resonance imaging (MRI); Right ventricular end-diastolic volume (RVEDV) and left ventricular end-diastolic volume (LVEDV) ratio = 2.0 measured by cardiac magnetic resonance imaging (MRI).;Inclusion criteria: Patients with New York Heart Association (NYHA) grade II and above, meet the first standard Patients with New York Heart Association (NYHA) grade I, meet the first and second. 1. meet one of the following conditions Pulmonary valve regurgitation score = 30% measured by Cardiac magnetic resonance imaging (MRI); Moderate (3+) to severe (4+) pulmonary arterial valves regurgitation measured by transthoracic ultrasonography; 2. Patients with New York Heart Association (NYHA) grade I should meet one of the following conditions Right ventricular end-diastolic volume index (RVEDVI) = 150 ml/m2 measured by cardiac magnetic resonance imaging (MRI); Right ventricular end-diastolic volume (RVEDV) and left ventricular end-diastolic volume (LVEDV) ratio = 2.0 measured by cardiac magnetic resonance imaging (MRI).;Inclusion criteria: Patients with New York Heart Association (NYHA) grade II and above, meet the first standard Patients with New York Heart Association (NYHA) grade I, meet the first and second. 1. meet one of the following conditions Pulmonary valve regurgitation score = 30% measured by Cardiac magnetic resonance imaging (MRI); Moderate (3+) to severe (4+) pulmonary arterial valves regurgitation measured by transthoracic ultrasonography; 2. Patients with New York Heart Association (NYHA) grade I should meet one of the following conditions Right ventricular end-diastolic volume index (RVEDVI) = 150 ml/m2 measured by cardiac magnetic resonance imaging (MRI); Right ventricular end-diastolic volume (RVEDV) and left ventricular end-diastolic volume (LVEDV) ratio = 2.0 measured by cardiac magnetic resonance imaging (MRI).
Exclusion criteria
Exclusion criteria: (1) Anatomical assessment is not appropriate, including the vascular entry can not fed the valve or RVOT-PA can not place the valve, or preoperative examination prompted the valve stent compression of the coronary artery; (2) Pulmonary hypertension [mean pressure > 30mmHg (1 mmHg = 0.133kPa)] measured by right heart catheter intervention; (3) Acute decompensated heart failure; (4) A history of infective endocarditis or currently suffering from active infection of endocarditis; (5) Known to be allergic to aspirin or heparin; (6) Life expectancy is less than 1 year; (7) women of childbearing age with urine or serum pregnancy test positive; (8) Participating in clinical trials of other unlisted products; (9) the patient or guardian is unwilling or unable to provide written informed consent or disobey the follow-up request; (10) According to the researchers to determine, the patient is not suitable for apical aortic valve implantation;;Exclusion criteria: (1) Anatomical assessment is not appropriate, including the vascular entry can not fed the valve or RVOT-PA can not place the valve, or preoperative examination prompted the valve stent compression of the coronary artery; (2) Pulmonary hypertension [mean pressure > 30mmHg (1 mmHg = 0.133kPa)] measured by right heart catheter intervention; (3) Acute decompensated heart failure; (4) A history of infective endocarditis or currently suffering from active infection of endocarditis; (5) Known to be allergic to aspirin or heparin; (6) Life expectancy is less than 1 year; (7) women of childbearing age with urine or serum pregnancy test positive; (8) Participating in clinical trials of other unlisted products; (9) the patient or guardian is unwilling or unable to provide written informed consent or disobey the follow-up request; (10) According to the researchers to determine, the patient is not suitable for apical aortic valve implantation;;Exclusion criteria: (1) Anatomical assessment is not appropriate, including the vascular entry can not fed the valve or RVOT-PA can not place the valve, or preoperative examination prompted the valve stent compression of the coronary artery; (2) Pulmonary hypertension [mean pressure > 30mmHg (1 mmHg = 0.133kPa)] measured by right heart catheter intervention; (3) Acute decompensated heart failure; (4) A history of infective endocarditis or currently suffering from active infection of endocarditis; (5) Known to be allergic to aspirin or heparin; (6) Life expectancy is less than 1 year; (7) women of childbearing age with urine or serum pregnancy test positive; (8) Participating in clinical trials of other unlisted products; (9) the patient or guardian is unwilling or unable to provide written informed consent or disobey the follow-up request; (10) According to the researchers to determine, the patient is not suitable for apical aortic valve implantation;;Exclusion criteria: (1) Anatomical assessment is not appropriate, including the vascular entry can not fed the valve or RVOT-PA can not place the valve, or preoperative examination prompted the valve stent compression of the coronary artery; (2) Pulmonary hypertension [mean pressure > 30mmHg (1 mmHg = 0.133kPa)] measured by right heart catheter intervention; (3) Acute decompensated heart failure; (4) A history of infective endocarditis or currently suffering from active infection of endocarditis; (5) Known to be allergic to aspirin or heparin; (6) Life expectancy is less than 1 year; (7) women of childbearing age with urine or serum pregnancy test positive; (8) Participating in clinical trials of other unlisted products; (9) the patient or guardian is unwilling or unable to provide written informed consent or disobey the follow-up request; (10) According to the researchers to determine, the patient is not suitable for apical aortic valve implantation;;Exclusion criteria: (1) Anatomical assessment is not appropriate, including the vascular entry can not fed the valve or RVOT-PA can not place the valve, or preoperative examination prompted the valve stent compression of the coronary artery; (2) Pulmonary hypertension [mean pressure > 30mmHg (1 mmHg = 0.133kPa)] measured by right heart catheter intervention; (3) Acute decompensated heart failure; (4) A history of infective endocarditis or currently suffering from active infection of endocarditis; (5) Known to be allergic to aspirin or heparin; (6) Life expectancy is less than 1 year; (7) women of childbearing age with urine or serum pregnancy test positive; (8) Participating in clinical trials of other unlisted products; (9) the patient or guardian is unwilling or unable to provide written informed consent or disobey the follow-up request; (10) According to the researchers to determine, the patient is not suitable for apical aortic valve implantation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aortic regurgitation grade measured by ultrasound;the mean right ventricular outflow tract (RVOT) pressure measured by ultrasound;Aortic regurgitation grade and ventricular volume (RVEDV; RV-EDVI; RV-EF) measured by MRI;New York Heart Association functional grade; | — |
Countries
China
Contacts
Public ContactXiaoke Shang;Xiaoke Shang;Xiaoke Shang;Xiaoke Shang;Xiaoke Shang ;;;;
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology;Union Hospital, Tongji Medical College, Huazhong University of Science and Technology;Union Hospital, Tongji Medical College, Huazhong University of Science and Technology;Union Hospital, Tongji Medical College, Huazhong University of Science and Technology;Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed