Status:
UNKNOWN
Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
Lead Sponsor:
Ningbo Jenscare Biotechnology Co., Ltd.
Conditions:
Severe Aortic Stenosis
Aortic Regurgitation
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality i...
Detailed Description
Aortic valve diseases is usually caused by rheumatic fever, congenital aortic valve structural abnormality or degenerative aortic valve calcification. Transcatheter aortic valve implantation (TAVI) ha...
Eligibility Criteria
Inclusion
- Subjects ≥ 65 years of age;
- Severe aortic stenosis, as defined by ultrasonic cardiogram (peak velocity ≥4.0 m/s, or mean transaortic systolic pressure gradient ≥40 mmHg, or an aortic valve area of \<1.0 cm2) or combined merger; severe aortic insufficiency (regurgitation ≥+++ or regurgitation area ≥0.3cm2) combined with left ventricular dilatation ( LVESD≥50mm or LVEDD≥65mm);or severe aortic valve insufficiency combined with left ventricular systolic dysfunction (LVEF\<50%);
- Symptoms suggestive of aortic stenosis, NYHA class III or IV;
- Patients who are considered unsuitable for surgery are considered by two or more than two cardiovascular specialists (≥6% using Society of Thoracic Surgeons scoring system estimation; or there is a severe and irreversible organ damage to the patient, such as lung disease, liver disease, kidney disease and so on; or the patient's physical weakness can not be tolerated by surgery; or have other factors affecting surgery, such as postoperative chest radiosurgery, thoracic deformity, and diffuse severe calcification of the aorta, etc);
- A life expectancy of \> 1 year;
- Voluntarily participate in and sign the informed consent form and willing to undergo the related examination and clinical follow-up.
Exclusion
- Untreated severe coronary stenosis and needs revascularization; or acute myocardial infarction occurred within 1 months, or coronary stent implantation in 1 month;
- Artificial heart valve and artificial valve ring have been implanted；
- Severe mitral insufficiency (regurgitation ≥+++) or mitral stenosis (valvular area\<1.5 cm2)；
- left ventricular or atrial thrombus;
- Aortic annulus diameter \<17mm or \>27 mm;
- Severe left ventricular dysfunction, ejection fraction \<20%；
- Severe pulmonary hypertension or severe right ventricular dysfunction；
- The ascending aortic ≥5cm or Aortic root diameter ≥4.5cm;
- Cerebrovascular event in last 3 months；
- Active endocarditis or other active infection;
- Severe renal failure and requires long-term dialysis treatment；
- Severe liver dysfunction；
- Active peptic ulcer；
- Severe coagulation dysfunction; it is known that all anticoagulant schemes are taboo or allergic, or anticoagulants can not be used in the process of testing；
- Severe respiratory failure；
- Severe Alzheimer's disease；
- Patients who were enrolled in any other study in one month;
- Other cases which the researchers believe that it is not suitable to participate in.
Key Trial Info
Start Date :
February 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT03788590
Start Date
February 23 2019
End Date
December 30 2021
Last Update
January 8 2019
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