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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.
This registry is a subgroup of Asian TAVR registry(NCT02308150) and Asian TAVR registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with bicuspid aortic valve stenosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcatheter aortic valve replacement | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death | 1 month | |
| Death | 6 months | |
| Death | 1 year | |
| Death | 2 years | |
| Death | 3 years | |
| Death | 4 years | |
| Death | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Death from cardiac cause | 1 month | |
| Death from cardiac cause | 6 months | |
| Death from cardiac cause |
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Inclusion Criteria:
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patients with bicuspid aortic valve stenosis
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| Name | Affiliation | Role |
|---|---|---|
| Seung-jung Park, MD, PhD | Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine | Principal Investigator |
| Gerald Yong, MD | Perth Cardiovascular Institute, Royal Perth Hospital 197 Wellington Street, Perth WA 6000, Australia | Principal Investigator |
| Edgar Tay, MD | Department of Cardiology, National University Hospital Singapore, 5 Lower Kent Ridge Road, Singapore 119074, Singapore | Principal Investigator |
| Fabian Nietlispach, MD, PhD | Department of Cardiology, University Heart Center, Raemistrasse 100, CH-8091 Zurich, Switzerland | Principal Investigator |
| Corrado Tamburino, MD | Division of Cardiology, Ferrarotto Hospital, University of Catania; ETNA Foundation Via Citelli 6, 95124, Catania, Italy | Principal Investigator |
| Thierry Lefèvre, MD | Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, France | Principal Investigator |
| Marie-Claude Morice, MD | Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, France | Principal Investigator |
| Jeroen J. Bax, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27609682 | Derived | Yoon SH, Lefevre T, Ahn JM, Perlman GY, Dvir D, Latib A, Barbanti M, Deuschl F, De Backer O, Blanke P, Modine T, Pache G, Neumann FJ, Ruile P, Arai T, Ohno Y, Kaneko H, Tay E, Schofer N, Holy EW, Luk NHV, Yong G, Lu Q, Kong WKF, Hon J, Kao HL, Lee M, Yin WH, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Kim HS, Butter C, Khalique OK, Schaefer U, Nietlispach F, Kodali SK, Leon MB, Ye J, Chevalier B, Leipsic J, Delgado V, Bax JJ, Tamburino C, Colombo A, Sondergaard L, Webb JG, Park SJ. Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis. J Am Coll Cardiol. 2016 Sep 13;68(11):1195-1205. doi: 10.1016/j.jacc.2016.06.041. |
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This is not a publicly funded trial.
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D002318 | Cardiovascular Diseases |
| D006349 | Heart Valve Diseases |
| D000082882 | Bicuspid Aortic Valve Disease |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D006330 | Heart Defects, Congenital |
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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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| 1 year |
| Death from cardiac cause | 2 years |
| Death from cardiac cause | 3 years |
| Death from cardiac cause | 4 years |
| Death from cardiac cause | 5 years |
| Stroke | 1 month |
| Stroke | 6 months |
| Stroke | 1 year |
| Stroke | 2 years |
| Stroke | 3 years |
| Stroke | 4 years |
| Stroke | 5 years |
| Myocardial infarction | 1 month |
| Myocardial infarction | 6 months |
| Myocardial infarction | 1 year |
| Myocardial infarction | 2 years |
| Myocardial infarction | 3 years |
| Myocardial infarction | 4 years |
| Myocardial infarction | 5 years |
| Repeat hospitalization | 1 month |
| Repeat hospitalization | 6 months |
| Repeat hospitalization | 1 year |
| Repeat hospitalization | 2 years |
| Repeat hospitalization | 3 years |
| Repeat hospitalization | 4 years |
| Repeat hospitalization | 5 years |
| Acute kidney injury | 1 month |
| Acute kidney injury | 6 months |
| Acute kidney injury | 1 year |
| Acute kidney injury | 2 years |
| Acute kidney injury | 3 years |
| Acute kidney injury | 4 years |
| Acute kidney injury | 5 years |
| Vascular complication | 1 month |
| Vascular complication | 6 months |
| Vascular complication | 1 year |
| Vascular complication | 2 years |
| Vascular complication | 3 years |
| Vascular complication | 4 years |
| Vascular complication | 5 years |
| Bleeding events | 1 month |
| Bleeding events | 6 months |
| Bleeding events | 1 year |
| Bleeding events | 2 years |
| Bleeding events | 3 years |
| Bleeding events | 4 years |
| Bleeding events | 5 years |
| Device success | 1 month |
| Device success | 6 months |
| Device success | 1 year |
| Device success | 2 years |
| Device success | 3 years |
| Device success | 4 years |
| Device success | 5 years |
| Early safety as a composite of all cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, valve related dysfunction requiring repeat procedure | 1 month |
| Clinical Efficacy as a composite of all cause mortality, all stroke, hospitalization for valve related symptoms or worsening congestive heart failure, NYHA class III or IV, prosthetic heart valve dysfunction | 1 month, 6 months, and annually at 1 to 5 years |
| Time related valve safety as a composite of structural valve deterioration, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, VARC bleeding(unless clearly unrelated to valve therapy) | from index procedure to 5 years |
| Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands |
| Principal Investigator |
| John G. Webb, MD | St. Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada | Principal Investigator |
| Susheel Kodali, MD | Herbert and Sandi Feinberg Interventional Cardiology, Heart Valve Center at Columbia University Medical Center/New York-Presbyterian Hospital, 177 Fort Washington Avenue, | Principal Investigator |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |