The primary purpose of this clinical trial is to evaluate the efficacy and safety of the transcatheter aortic valve system in the treatment of patients with failing bioprosthetic valve
The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Transcatheter valve-in-valve replacement
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGComposite of all-cause mortality and valve-related reintervention
Time frame: 1 year
Technical success
1. Freedom from death; 2. Successful vascular delivery and retrieval of transcatheter valve delivery system; 3. Correct position of transcatheter valve; 4. No need for any emergency surgery or re-intervention (including device-related and surgical approach-related); 5. Adequate performance of prosthesis (No moderate or greater stenosis or regurgitation).
Time frame: 30 days
Procedural Success
1. Device success; 2. No severe complications of the following: death; stroke; life threatening bleeding; major vascular complications; secondary severe cardiac organic disease (eg: aortic dissection, apical aneurysm formation, left ventricular outflow tract obstruction, etc.); stage 2 or 3 AKI; MI or coronary ischemia requiring PCI or CABG; severe hypotension; heart failure or respiratory failure requiring high-dose vasoactive drugs/or cardiac mechanical assist devices; any valve-related dysfunction including migration, thrombosis, or other complication requiring surgery or repeat intervention.
Time frame: 30 days
Device success
1. Freedom from stroke; 2. Prosthetic heart valve function is normal (including no displacement, calcification, thrombosis, hemolysis, or endocarditis); 3. No need for any emergency surgery or secondary intervention (including device-related and surgical approach-related); 4. No prosthetic valve stenosis; 5. Prosthetic valve regurgitation \<2+ (including central leakage and paravalvular leakage), and no related hemolysis; 6. LVOT pressure gradient increased \<20mmHg.
Time frame: 30 days
All-cause mortality
All-cause mortality included cardiac,non-cardiac death and other ominous death.
Time frame: 30 days
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