A Prospective，Multicenter, Single-arm Clinical Trial to Evaluate Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Composite event rate at 30 days
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
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;
Outcomes
Primary Outcomes
Composite event rate at 30 days
Time Frame: 30 days after procedure
Patient-oriented composite event including all-cause death，severe stroke，myocardial infarction, permanent pacemaker implantation，surgical reoperation and valve-in-valve.
Secondary Outcomes
- Device success rate (immediately after procedure)(Immediately after procedure)
- Procedure success rate(72 hours after procedure/prior to discharge)
- Cardiac function improvement(30 days after procedure)
- Quality of life of patients(30 days after procedure)