A Prospective, Multicenter, Single-armed Trial That Aims to Evaluate the Safety and Efficacy of Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Aortic Stenosis
- Sponsor
- Ningbo Jenscare Biotechnology Co., Ltd.
- Enrollment
- 133
- Primary Endpoint
- All-cause mortality
- Last Updated
- 7 years ago
Overview
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 in severe aortic stenosis or insufficiency patients who are high risk or ineligible for aortic valve replacement.
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) has evolved as an alternative to surgical aortic valve replacement (SAVR) with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis, who were considered to be at very high or prohibitive operative risk. This project take the incidence of all-cause mortality at 12 months since TAVI as the primary endpoint to evaluate the safety and efficacy, then take the procedure success rate, device success rate, incidence of severe adverse events, device operative performance, prosthetic valve performance and quality of life to evaluate transcatheter artificial aortic valve and transcatheter artificial heart values delivery system of Ningbo Jenscare Biotechnology Co., Ltd. in clinical application.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: 12 month
Cumulative incidence of a combination of all cause death at 12 month after TAVI
Secondary Outcomes
- Procedure success rate(During the TAVI procedure)
- Evaluation and improvement of quality of life(Preoperative and 30 days, 3 months, 6 months, 12 months after TAVI)
- Device success rate(During the TAVI procedure)
- Incidence of severe adverse events(During the TAVI procedure and 3 days,7 days, 30 days, 3 months, 6 months, 12 months after TAVI)
- Assessment of device operative performance(During the TAVI procedure)
- Echocardiographic assessment of valve performance(30 days, 3 months, 6 months, 12 months after TAVI)