The objective of this study is to evaluate the safety and effectiveness of the Prizvalve transcatheter aortic valve in subjects who are at high or greater risk with failing bioprosthetic valves.
Prospective, single arm, multicenter study
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Transcatheter valve-in-valve replacement procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted.
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
Xi'an, Shaanxi, China
All-cause mortality
The primary end point is the 30 days all-cause mortality
Time frame: At 30 days
Device success
Device Success Criteria 1. Successful vascular access, delivery, deployment and implantation of the study device, with complete removal of the delivery system from the body; 2. The implanted prosthetic valve achieves the intended haemodynamic performance, defined as the absence of moderate or greater prosthetic valve stenosis or regurgitation.
Time frame: immediate post-surgical
Procedural success
Procedural Success Criteria 1. Correct anatomical positioning of the implanted valve; 2. No intra-operative or immediate post-procedural death (≤ 72 h); 3. Achievement of the intended therapeutic goal without occurrence of any major intra-operative complication, including but not limited to coronary obstruction, ventricular septal perforation, damage or dysfunction of other native valves, cardiac tamponade, procedure termination, or conversion to open cardiac surgery.
Time frame: immediate post-surgical
All-cause mortality
Time frame: At 6 months, 1 year
The incidence of rehospitalization
Time frame: At 30 days, 6 months, 1 year
The incidence of myocardial infarction
Time frame: At 30 days, 6 months, 1 year
The incidence of stroke
Time frame: At 30 days, 6 months, 1 year
The incidence of bleeding
Time frame: At 30 days, 6 months, 1 year
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The incidence of acute kidney injury
Time frame: At 30 days, 6 months, 1 year
The incidence of permanent pacemaker implantation
Time frame: At 30 days, 6 months, 1 year
The incidence of vascular and access-related complications
Time frame: At 30 days, 6 months, 1 year
The incidence of procedure-related complications
Time frame: At 30 days, 6 months, 1 year
The incidence of valve dysfunction
Time frame: At 30 days, 6 months, 1 year
The incidence of NYHA functional class improvement
the New York Heart Association to quantify the severity of functional limitation and symptoms attributable to cardiac disease
Time frame: At 30 days, 6 months, 1 year
The incidence of quality-of-life improvement
By SF-12 Health Survey (Short-Form 12-item Health Survey)
Time frame: At 30 days, 6 months, 1 year
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: At 30 days, 6 months, 1 year