Status:
COMPLETED
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System
Lead Sponsor:
Peijia Medical Technology (Suzhou) Co., Ltd.
Collaborating Sponsors:
General Hospital of Shenyang Military Region
Shanghai Zhongshan Hospital
Conditions:
Aortic Stenosis
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multi...
Detailed Description
The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multi...
Eligibility Criteria
Inclusion
- Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;
- Age ≥70 years old;
- Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area \< 0.8cm2, or effective aortic valve orifice the product index is \< 0.5cm2/m2);
- Appear obvious symptoms caused by aortic stenosis, NYHA class Ⅱ or higher;
- The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;
- The life expectancy of the patient after implantation of the prosthetic valve was evaluated by the cardiac team (at least two specialists in cardiovascular surgery) as more than one year;
- Patients with aortic ring diameter ≥18mm and ≤29mm (cardiac CT measurement);
- The diameter of the ascending aorta of the patient was \< 50mm.
Exclusion
- Patients with bacteremia or toxemia;
- previous history or active endocarditis;
- Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with increased creatine kinase isoenzyme and/or troponin T) within 30 days;
- Echocardiography found any intracardiac mass, left ventricle or atrial thrombosis, vegetations;
- Symptomatic atrial fibrillation that cannot be improved by medication;
- Familial hypertrophic cardiomyopathy;
- Mitral valve and tricuspid valve insufficiency (reflux Ⅱ level above);
- Prior aortic valve grafts (mechanical or biological valve stents);
- Known allergy to contrast agent, aspirin, heparin, ticlopidine, nickel-titanium memory alloy, or bovine products;
- Known to be contraindication or allergic to all anticoagulant regimens, or unable to use anticoagulant during the test;
- Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.)
- Current drug abuse problem (e.g., alcohol, cocaine, heroin, etc.); Plan to undergo surgery that may cause nonadherence to protocol or confusion in data interpretation.
- Cerebrovascular accident (CVA) in the past 6 months;
- Patients with common or internal carotid or vertebral artery stenosis (\> 70%);
- WBC count \< 3×109/L, platelet count \< 50×109/ L;
- Hemoglobin \< 90g/L;
- Patients with severe coagulation dysfunction;
- Severe left ventricular dysfunction, left ventricular ejection fraction \< 20%;
- Abdominal or thoracic aortic aneurysm;
- Hepatic encephalopathy or acute active hepatitis;
- Receiving dialysis or a baseline creatinine level of \> 3.0 mg/dL (266μmol/L);
- Have bleeding tendency or history of coagulation disease or refuse blood transfusion;
- Have active gastric ulcer or active gastrointestinal (GI) bleeding;
- Suffer from neurological diseases that seriously affect the ability to move or live in daily life;
- People with mental illness or mental disorder who cannot express themselves normally;
- Need emergency surgery for any reason;
- Screening participants who had participated in other drug or medical device clinical trials within the previous 3 months;
- Other conditions considered by the investigator to be inappropriate for participation in this clinical trial.
Key Trial Info
Start Date :
December 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2020
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04744857
Start Date
December 13 2019
End Date
October 16 2020
Last Update
February 21 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peiga Medical Technology (Suzhou) Co., Ltd
Suzhou, Jiangsu, China, 215025