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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04815785
Other study ID # CSP12000-2
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 22, 2017
Est. completion date May 30, 2024

Study information

Verified date October 2023
Source Peijia Medical Technology (Suzhou) Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 objective performance criteria.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date May 30, 2024
Est. primary completion date May 11, 2020
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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

Study Design


Intervention

Device:
TaurusOne® transcatheter aortic valve replacement system
The TaurusOne® Transcatheter Aortic Valve System consists of an aortic valve, an associated delivery catheter and a loading system. The aortic valve consists of a self-expanding nitinol frame, a sealing skirt and valve leaflets, which are made of bovine pericardium. The delivery system is mainly composed of conical head, opacity ring, inner tube, top ring, middle tube, outer tube, booster rod, stress diffusion catheter, handle, etc. The outflow end of the aortic valve is provided with three fixing holes evenly distributed on the circumference on the top ring of the delivery catheter, so as to facilitate the installation, delivery and release of the aortic valve. Before the operation, the aortic valve needs to be installed into the sheath of the delivery catheter as required.

Locations

Country Name City State
China Peiga Medical Technology (Suzhou) Co., Ltd Suzhou Jiangsu

Sponsors (7)

Lead Sponsor Collaborator
Peijia Medical Technology (Suzhou) Co., Ltd. Fu Wai Hospital, Beijing, China, General Hospital of Shenyang Military Region, Second Affiliated Hospital, School of Medicine, Zhejiang University, Second Xiangya Hospital of Central South University, The Second Affiliated Hospital of Harbin Medical University, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Product performance evaluation Product Performance includes grip loading, emptying , delivery, release, retrace, development and retrieval performance of delivery catheter system. Every item measured by:1=good 2=average 3=poor. Immediate after procedure
Other Operative complication The rate of operative complication Immediately after procedure
Other The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs) Incidence of MACCEs (mortality, stroke, myocardial infarction, and so on surgery, arrhythmias, conduction blocks) during the trial 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Other Incidence of major adverse valve-related events (MAVREs) during the trial including prosthetic valve-related death, permanent cardiac pacemaker implantation, permanent cardiac defibrillator implantation, prosthetic valve embolism, prosthetic valve thrombosis, prosthetic valve dysfunction. 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Other hemorrhage Rate of patients with hemorrhage during the trial. 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Other acute kidney injury Rate of patients with acute kidney injury during the trial. 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Other Vascular Complications Vascular Complications 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Other Other TAVI related complications Rate of patients with Other TAVI related complications during the trial. Other TAVI related complications include conversion to surgery, accidental cardiopulmonary mechanical assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, pericardial tamponade, endocarditis, valvular thrombosis, valvular ectopic (displacement, embolization, erroneous release), etc. 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Other Valvular function Valvular function include valve stenosis, valve regurgitation, valve function (such as opening area, pressure gradient), perivalvular leakage, etc.
There is Echo standard in VARC II to apply for valvular function assessment.
30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Primary All-cause mortality at 12 months All-cause mortality 12 months
Secondary Device success rate (Immediate after procedure) Successful delivery and release of vascular access and prosthetic aortic valve, and successful withdrawal of the delivery catheter
Accurate placement of prosthetic aortic valve at the anatomical site
Prosthetic aortic valve meets the desired requirements (mean valve gradient < 20 mm Hg or maximal flow velocity < 3 m/s; No severe prosthetic valve regurgitation or perivalvular leak)
Immediate after procedure
Secondary Procedure success rate A successful procedure is defined as successful implantation of the prosthetic aortic valve at the correct anatomical site 72 hours after the operation or before discharge without severe prosthetic valve regurgitation or perivalvular leak. 72 hours after procedure/prior to discharge
Secondary Cardiac function improvement NYHA functional classification 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
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