Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit for Use as an Adjunct to Transcatheter Aortic Valve Replacement
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Whether or not TAVR procedures are performed with a TAVR assist system
TAVR by manual
Technical Success at exit from OR, hybrid room or cath lab post-index procedure
Absence of procedural mortality; and Successful access, delivery, and retrieval of transcatheter delivery system; and Deployment and correct positioning of a single intended THV; and Freedom from re-intervention related to the device or access procedure
Time frame: Immediate after procedure
Device Success
Absence of procedure mortality; and Correct position of a single prosthetic heart valve Intended performance of the prosthetic heart valve (i.e., no prosthesis mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s; and no moderate or severe prosthetic valve regurgitation) Intended performance of the prosthetic heart valve (i.e., no prosthesis mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s; and no moderate or severe prosthetic valve regurgitation)
Time frame: 30 days
Cardiac function changement
Cardiac function changement is accessed by NYHA cardiac function classification increases from baseline to 30 days
Time frame: Baseline,30 days
Prosthetic aortic valve function
Effective orifice area, mean transvalvular pressure difference, degree of regurgitation (mid-valve, peri-valve), degree of stenosis, etc.
Time frame: 1、immediately after the procedure; 2、3 days; 3、30 days
Duration of aortic valve replacement
Time from start of delivery of prosthetic aortic valve by valve delivery system to successful implantation of prosthetic aortic valve
Time frame: During the procedure
Total exposure of the operator to radiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The doctor wears radiation detection equipment and records the total radiation exposure during the surgical procedure
Time frame: During the procedure
Number of surgical staff
Time frame: During the procedure
Evaluation of Device Performance with questionnaires
For test group only,using questionnaires to evaluate Device performance
Time frame: immediately after the procedure