To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Lotus Valve System
2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang, China
Combined rate of death from any cause, myocardial infarction, and stroke
Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)
Time frame: 30 days following procedure
Number of participants with procedural complications
Time frame: 30 days following procedure
Functional status (NYHA-classification)
Time frame: 6 months following procedure
Echocardiographic prosthesis status
Time frame: 6 months following procedure
Quality of Life (SF-12)
Time frame: 6 months following procedure
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