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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Using the grip-loading system, the artificial aortic valve was squeezed and loaded into the sheath of the transporter through the vascular approach.The artificial aortic valve is delivered and positioned at the correct anatomical position for release. For example, the artificial main valve is displayed after partial release If the aortic valve is not in the correct anatomical position, the artificial aortic valve can be recovered and placed into the sheath tube of the transporter for re-positioning and release.
Peiga Medical Technology (Suzhou) Co., Ltd
Suzhou, Jiangsu, China
Composite event rate at 30 days
Patient-oriented composite event including all-cause death,severe stroke,myocardial infarction, permanent pacemaker implantation,surgical reoperation and valve-in-valve.
Time frame: 30 days after procedure
Device success rate (immediately after procedure)
Device success is defined as * Vascular access, artificial aortic valve delivery and release were successful, and the delivery catheter was successfully withdrawn. * The artificial aortic valve was implanted in an anatomically accurate position. * The artificial aortic valve met the expected requirements (mean transvalvular pressure difference \< 20mmHg or maximum flow rate \< 3m/s; No serious manual initiative valve regurgitation or perivalvular leakage)
Time frame: Immediately after procedure
Procedure success rate
Procedure success is defined as the artificial aortic valve successfully implanted in the correct anatomical position 72h after surgery or before discharge without severe artificial aortic valve regurgitation or perivalvular leakage.
Time frame: 72 hours after procedure/prior to discharge
Cardiac function improvement
Cardiac function improvement is accessed by NYHA cardiac function classification increases from baseline to 30 days.
Time frame: 30 days after procedure
Quality of life of patients
Quality of Life of patients accessed by EuroQol-5 Dimensions (EQ-5D) Questionnaire. The higher scores mean a worse health state. Recording changes from baseline to 30 days.
Time frame: 30 days after procedure
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