This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve during TAVR in the real-world setting.
The study is designed to evaluate the safety and effectiveness of the Alwide Plus balloon catheter for pre-dilatation of the aortic valve during in transcatheter aortic valve replacement in the real-world setting, with TAVI device success at immediate post-procedure as the primary endpoint. The immediate post-procedural pre-dilation success, all-cause mortality, stroke, bleeding, acute kidney injury, permanent pacemaker implantation, major vascular complication, valve function at post-procedure and discharge, and post-dilation success will be used as secondary endpoints.This is a prospective, multi-center, post market clinical investigation. 75 patients will be enrolled in this clinical investigation. All subjects will undergo telephone follow-up at 30 days post-procedure.
Study Type
OBSERVATIONAL
Enrollment
75
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Yan'an Hospital of Kunming City
Kunming, Yunnan, China
Guangdong Provincial People's Hospital
Guangzhou, China
Percentage of patients with TAVI device success at immediate post-procedure
TAVI device success, defined as (meeting all the following criteria): Freedom from mortality; Successful access, delivery, deployment, implantation of the valve, and retrieval of the delivery system; Correct positioning of the prosthetic heart valve into the proper anatomical location; Intended performance of the valves (mean gradient \<20mmHg, or peak velocity \<3 m/s, and no severe aortic regurgitation or paravalvular leakage).
Time frame: Immediate post-procedure
Percentage of patients with balloon pre-dilation success
defined as successful access, delivery and dilation the aortic valve, and retrieval for the AlwideTM Plus balloon catheter
Time frame: Immediate post-procedure
Percentage of paitents with balloon post-dilation success
defined as successful access, delivery and dilation the transcatheter aortic valve, and retrieval for the AlwideTM Plus balloon catheter
Time frame: Immediate post-procedure
Incidence of all-cause mortality, disabling and non-disabling stroke, life-threatening or disabling bleeding, major bleeding, acute kidney injury(AKIN≥2), major vascular complications and new permanent pacemaker implantation
Definition following VARC-2 criteria
Time frame: Immediate post-procedure and 30 days post-procedure
Prosthetic valve performance-mean transvalular pressure gradient
Prosthetic valve performance-mean pressure gradient(assessed by echocardiography), unit -mmHg
Time frame: Immediate post-procedure and discharge(within 7 days post-procedure)
Prosthetic valve performance-orifice area
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Prosthetic valve performance-orifice area(assessed by echocardiography), unit -cm2
Time frame: Immediate post-procedure and discharge(within 7 days post-procedure)
Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage)
Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage), none/trace/mild/moderate/severe
Time frame: Immediate post-procedure and discharge(within 7 days post-procedure)