Clinical trial NCT04744857: Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System
Official title: A Prospective，Multicenter, Single-arm Clinical Trial to Evaluate Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Peijia Medical Technology (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: General Hospital of Shenyang Military Region
name: Shanghai Zhongshan Hospital
name: Guangdong Provincial People's Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Air Force Military Medical University, China
name: West China Hospital
name: Beijing Anzhen Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Central South University
name: Fu Wai Hospital, Beijing, China
name: China National Center for Cardiovascular Diseases
name: Shanghai Lingshi Medical Technology Co., Ltd
First posted: 2021-02-09
Enrollment: 85
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Preliminary data from the TaurusOne® clinical trial show good safety and efficacy in this trial without altering the artificial aorta To evaluate the safety and effectiveness of a transporter with a recoverable function. Take TaurusOne® in a clinical trial of compounding Endpoint event incidence was used as a target control.
Primary purpose: TREATMENT

Brief summary: The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical trial.

Detailed description: The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical trial. According to the inclusion and exclusion criteria, sixty patients are planed been enrolled and implanted with TaurusOne® .Patients are seen at pre and post procedure, discharge, 30 days. The main follow-up included clinical symptoms and signs, cardiac ultrasound, CT, etc. The outcome included immediate device success, procedure success, And the major cardiovascular and cerebrovascular adverse events (MACCE, including mortality, stroke, myocardial infarction, reoperation, arrhythmia, conduction block).

Eligibility criteria: Inclusion Criteria:

* Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;
* Age ≥70 years old;
* Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area \< 0.8cm2, or effective aortic valve orifice the product index is \< 0.5cm2/m2);
* Appear obvious symptoms caused by aortic stenosis, NYHA class Ⅱ or higher;
* The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;
* The life expectancy of the patient after implantation of the prosthetic valve was evaluated by the cardiac team (at least two specialists in cardiovascular surgery) as more than one year;
* Patients with aortic ring diameter ≥18mm and ≤29mm (cardiac CT measurement);
* The diameter of the ascending aorta of the patient was \< 50mm.

Exclusion Criteria:

* Patients with bacteremia or toxemia;
* previous history or active endocarditis;
* Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with increased creatine kinase isoenzyme and/or troponin T) within 30 days;
* Echocardiography found any intracardiac mass, left ventricle or atrial thrombosis, vegetations;
* Symptomatic atrial fibrillation that cannot be improved by medication;
* Familial hypertrophic cardiomyopathy;
* Mitral valve and tricuspid valve insufficiency (reflux Ⅱ level above);
* Prior aortic valve grafts (mechanical or biological valve stents);
* Known allergy to contrast agent, aspirin, heparin, ticlopidine, nickel-titanium memory alloy, or bovine products;
* Known to be contraindication or allergic to all anticoagulant regimens, or unable to use anticoagulant during the test;
* Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.)
* Current drug abuse problem (e.g., alcohol, cocaine, heroin, etc.); Plan to undergo surgery that may cause nonadherence to protocol or confusion in data interpretation.
* Cerebrovascular accident (CVA) in the past 6 months;
* Patients with common or internal carotid or vertebral artery stenosis (\> 70%);
* WBC count \< 3×109/L, platelet count \< 50×109/ L;
* Hemoglobin \< 90g/L;
* Patients with severe coagulation dysfunction;
* Severe left ventricular dysfunction, left ventricular ejection fraction \< 20%;
* Abdominal or thoracic aortic aneurysm;
* Hepatic encephalopathy or acute active hepatitis;
* Receiving dialysis or a baseline creatinine level of \> 3.0 mg/dL (266μmol/L);
* Have bleeding tendency or history of coagulation disease or refuse blood transfusion;
* Have active gastric ulcer or active gastrointestinal (GI) bleeding;
* Suffer from neurological diseases that seriously affect the ability to move or live in daily life;
* People with mental illness or mental disorder who cannot express themselves normally;
* Need emergency surgery for any reason;
* Screening participants who had participated in other drug or medical device clinical trials within the previous 3 months;
* Other conditions considered by the investigator to be inappropriate for participation in this clinical trial.

Primary outcomes:
measure: Composite event rate at 30 days
timeFrame: 30 days after procedure
Secondary outcomes:
measure: Device success rate (immediately after procedure)
timeFrame: Immediately after procedure
measure: Procedure success rate
timeFrame: 72 hours after procedure/prior to discharge
measure: Cardiac function improvement
timeFrame: 30 days after procedure
measure: Quality of life of patients
timeFrame: 30 days after procedure
Other outcomes:
measure: Product performance evaluation
timeFrame: Immediately after procedure
measure: operative complication
timeFrame: Immediately after procedure
measure: The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)
timeFrame: 30 days after procedure
measure: Incidence of major adverse valvular events (MAVREs) during the trial
timeFrame: 30 days after procedure
measure: hemorrhage
timeFrame: 30 days after procedure
measure: acute kidney injury
timeFrame: 30 days after procedure
measure: Other TAVI related complications
timeFrame: 30 days after procedure
measure: Valvular function
timeFrame: 30 days after procedure
Locations:
city: Suzhou
country: China
facility: Peiga Medical Technology (Suzhou) Co., Ltd
state: Jiangsu
Study officials:
References: