Status:
UNKNOWN
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
Lead Sponsor:
Peijia Medical Technology (Suzhou) Co., Ltd.
Collaborating Sponsors:
Fu Wai Hospital, Beijing, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Aortic Stenosis
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04815785
Start Date
September 22 2017
End Date
May 30 2024
Last Update
October 24 2023
Active Locations (1)
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1
Peiga Medical Technology (Suzhou) Co., Ltd
Suzhou, Jiangsu, China, 215025