Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis

Peijia Medical

Status

Active, not recruiting

Conditions

Aortic Stenosis

Treatments

Device: TaurusOne® transcatheter aortic valve replacement system

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04815785

CSP12000-2

Details and patient eligibility

About

To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance criteria.

Enrollment

120 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
Age ≥ 70 years;
Patients with severe calcific aortic stenosis confirmed by echocardiography (Transaortic flow velocity ≥ 4.0 m/s, or aortic-valve gradient ≥ 40 mmHg (1 mmHg = 0.133 kPa), or aortic valve area < 0.8 cm2, or effective orifice area < 0.5 cm2/m2);
Patients who have symptoms obviously caused by aortic stenosis, NYHA Class II or worse;
Patients who are unsuitable for conventional surgery evaluated by the cardiac team (including at least two cardiovascular surgeons) [13] *;
Life expectancy after implantation of prosthetic valve is more than one year evaluated by the cardiac team (including at least two cardiac surgeons);
Aortic annulus diameter ≥ 18 mm and ≤ 29 mm (measured by cardiac CT);
Ascending aorta diameter < 50 mm

*: If the patient meets any of the following criteria judged by a multidisciplinary cardiac team composed of cardiologists and cardiovascular surgeons, radiologists, anesthesiologists, etc. (at least two cardiovascular surgeons), the patient will be identified as unsuitable for conventional surgery (at least STS ≥ 8 points):
Estimated risk of surgery-related death or disability > 50% within 1 year;
≥3 major organ damage that could not be improved by surgery;
Obstacles related to surgical procedures judged as serious

Exclusion criteria

Patients with bacteremia or toxemia;
Previous endocarditis or active endocarditis;
Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with elevated creatine kinase isoenzyme and troponin T) within 30 days;
Any intracardiac mass, left ventricular or atrial thrombus, vegetation on echocardiography;
Symptomatic atrial fibrillation that cannot be improved by drug therapy;
Familial hypertrophic cardiomyopathy;
Mitral or tricuspid valve insufficiency (grade II regurgitation or higher);
Previous aortic valve graft (mechanical or bioprosthetic valve);
Known allergies to contrast agents, aspirin, heparin, ticlopidine drugs, nitinol shape memory alloy, or bovine products;
Known contraindications or allergies to anticoagulant regimens, or inability to use anticoagulants throughout the trial;
Other serious diseases that may reduce life expectancy to less than 12 months (such as clinically recurrent or metastatic cancer, congestive heart failure, etc.);
Current substance abuse problems (e.g., alcohol, cocaine, heroin, etc.);
Scheduled to undergo surgery that may result in protocol noncompliance or confounding in data interpretation.
Cerebrovascular accident (CVA) in the past 6 months;
Patients with common carotid artery or internal carotid artery or vertebral artery stenosis (>70%);
White blood cell count <3×109/L, platelet count <50×109/L;
Hemoglobin < 90 g/L;
Patients with severe coagulopathy;
Severe left ventricular dysfunction, left ventricular ejection fraction < 20%;
Abdominal or thoracic aortic aneurysm;
Hepatic encephalopathy or acute active hepatitis;
On dialysis or baseline creatinine level > 2.5 mg/dL (221 μ mol/L);
Bleeding tendency or history of coagulation disease or refusal of blood transfusion;
Patients with active peptic ulcer or active gastrointestinal (GI) bleeding;
Patients with neurological diseases that seriously affect mobility and activities of daily living;
Patients with mental illness or psychological disorders who are unable to communicate effectively;
Patients who need emergency surgery for any reason;
Patients who have participated in other drug or medical device clinical trials within 3 months prior to screening;
Other conditions that make the patient ineligible to participate in this clinical trial in judgement of investigators