Clinical Trial in China for Aortic Valve Stenosis
Diseases of Aortic Valve, Aortic Stenosis Disease
About this trial
This is an interventional treatment trial for Diseases of Aortic Valve
Eligibility Criteria
Inclusion Criteria: Age ≥ 65; Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II; Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluated as inoperable by the surgical team [defined as rate of death #50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: age of inoperable patients can be expanded to ≥ 50); Aortic valve anatomy is suitable for TAVR evaluated by the investigators; Patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups. Exclusion Criteria: Active endocarditis; Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure; Cerebrovascular accident (CVA) occurred within 30 days before procedure; The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium; Hypertrophic obstructive cardiomyopathy; Other valve diseases that need interventions; Previous aortic valve implantation (mechanical or biological); Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products; Known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the TAVR; In presence one of the following (from selection to the day of procedure index): a other diseases that may shorten life expectancy to less than 12 months (recurrent or metastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroin and so on); c planned additional operations that may result in incompliance or data confusion; Stenosis of common carotid artery, internal carotid artery or vertebral artery #70%; Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%; Hepatic encephalopathy or acute active hepatitis; Receiving hemodialysis; Bleeding tendency or history of coagulopathy or refuse to receive transfusion; Active gastrointestinal (GI) ulcer or bleeding; Severe dementia; Patients who need emergency surgery for any reason; Patients are participating in other drugs or medical devices clinical trial; Pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (Women suspected of pregnancy must have a negative serum or urine test for human villous gonadotropin prior to enrollment in the study); Other inappropriate occasions according to the investigators.
Sites / Locations
- Beijing Anzhen Hospital,Capital Medical UniversityRecruiting
- Chinese PLA General HoapitalRecruiting
- Peking University Third HospitalRecruiting
- Xuanwu Hospital Capital Medical UniversityRecruiting
- Xinqiao Hospital Army Medical Univer SityRecruiting
- Guangdong Academy of Medical SciencesRecruiting
- Nanjing Drum Tower HospitalRecruiting
- Zhongshan HospitalRecruiting
- WEST CHINA hospitalRecruiting
- The First Affiliated of Soochow UniversityRecruiting
- Xijing Hospital of the Fourth Military Medical UniversityRecruiting
- Xiamen Cardiovascular Hospital Xiamen UniversityRecruiting
- Fuwai Yunnan Cardiovascular HospitalRecruiting
- The Second Affiliated Hospital of Zhejiang UniversityRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Arms of the Study
Arm 1
Experimental
Experimental: Treatment
Device: J-Valve® valve delivery system, Transvascularized biological aortic valve system