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The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.
Subjects enrolled are those who undergo physical exams and screening tests and were classified as a patient with symptomatic aortic stenosis or severe aortic regurgitation. They are then performed transcatheter aortic valve replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic Stenosis/regurgitation | Experimental | Transcatheter aortic valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcatheter aortic valve replacement | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| stroke | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | |
| death from cardiac causes | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianbao Liu, MD | Contact | +86-13857173887 | liuxb2009@hotmail.com | |
| Jian-an Wang, MD,PhD | Contact | +86-13805786328 | Wang_jian_an@tom.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian-an Wang, MD,PhD | Second Affiliated Hospital of Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital, School of Medicine at Zhejiang University | Recruiting | Hanzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39080364 | Derived | Fan J, Chen J, Zhu G, Xu Y, Ng S, Dai H, Zhou D, Yidilisi A, Qi X, Liu X, Wang J. Impact of repositioning on brain injury following transcatheter aortic valve replacement with a self-expanding valve. Sci Rep. 2024 Jul 30;14(1):17554. doi: 10.1038/s41598-024-67748-6. | |
| 38816554 | Derived | Zhou Q, Wen J, Zhu Q, Fan J, Guan X, Chen X, He Y, Guo Y, Jiang J, Ding X, Pu Z, Huang Z, Li C, Zhang M, Liu X, Xu X, Wang J. Long-term prosthetic-associated subclinical thrombotic events evaluation by cardiac CTA after transcatheter aortic valve implantation: incidence and outcomes. Insights Imaging. 2024 May 30;15(1):125. doi: 10.1186/s13244-024-01681-0. |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| myocardial infarction |
| 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years |
| repeated hospitalization | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years, 10 years |
| acute kidney injury | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years |
| vascular complications | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years |
| bleeding events | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years |
| device success | Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation) | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years |
| Functional Improvement from baseline per New York Heart Association functional classification | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years |
| permanent pacemaker implantation | number of patients who develop permanent third-degree or type 2(Mobitz) Secondary atrioventricular block after transcatheter aortic valve replacement and need permanent pacemaker implantation. | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years |
| transcatheter valve failure | leaflet thrombosis formation, reduced leaflet motion or leaflet thickening of the prosthetic valve | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years |
| changes in ascending aorta diameter | 1 year,2 years, 3 years, 4 years, 5 years,10 years |
| Death from all causes | 30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years,10 years |
| 35413789 | Derived | Hu P, Chen H, Wang LH, Jiang JB, Li JM, Tang MY, Guo YC, Zhu QF, Pu ZX, Lin XP, Ng S, Liu XB, Wang JA. Elevated N-terminal pro C-type natriuretic peptide is associated with mortality in patients undergoing transcatheter aortic valve replacement. BMC Cardiovasc Disord. 2022 Apr 12;22(1):164. doi: 10.1186/s12872-022-02615-8. |
| 33243378 | Derived | Fan J, Fang X, Liu C, Zhu G, Hou CR, Jiang J, Lin X, Wang L, He Y, Zhu Q, Ng S, Chen Z, Hu H, Liu X, Wang J, Leon MB. Brain Injury After Transcatheter Replacement of Bicuspid Versus Tricuspid Aortic Valves. J Am Coll Cardiol. 2020 Dec 1;76(22):2579-2590. doi: 10.1016/j.jacc.2020.09.605. |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |