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The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter aortic valve replacement | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Death from any cause | 1 month |
| Death | Death from any cause | 1 year |
| Death | Death from any cause | 2 years |
| Death | Death from any cause | 3 years |
| Death | Death from any cause | 4 years |
| Death | Death from any cause | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Death from cardiac cause | Death from cardiac cause | 1 month |
| Death from cardiac cause | Death from cardiac cause | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung-Han Yoon, M.D. | Contact | 3104237426 | Sunghan.Yoon@cshs.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32854836 | Derived | Yoon SH, Kim WK, Dhoble A, Milhorini Pio S, Babaliaros V, Jilaihawi H, Pilgrim T, De Backer O, Bleiziffer S, Vincent F, Shmidt T, Butter C, Kamioka N, Eschenbach L, Renker M, Asami M, Lazkani M, Fujita B, Birs A, Barbanti M, Pershad A, Landes U, Oldemeyer B, Kitamura M, Oakley L, Ochiai T, Chakravarty T, Nakamura M, Ruile P, Deuschl F, Berman D, Modine T, Ensminger S, Kornowski R, Lange R, McCabe JM, Williams MR, Whisenant B, Delgado V, Windecker S, Van Belle E, Sondergaard L, Chevalier B, Mack M, Bax JJ, Leon MB, Makkar RR; Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry Investigators. Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Sep 1;76(9):1018-1030. doi: 10.1016/j.jacc.2020.07.005. |
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| ID | Term |
|---|---|
| D000082882 | Bicuspid Aortic Valve Disease |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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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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| Death from cardiac cause | Death from cardiac cause | 2 years |
| Death from cardiac cause | Death from cardiac cause | 3 years |
| Death from cardiac cause | Death from cardiac cause | 4 years |
| Death from cardiac cause | Death from cardiac cause | 5 years |
| Stroke | disabling and non-disabling stroke | 1 month |
| Stroke | disabling and non-disabling stroke | 1 year |
| Stroke | disabling and non-disabling stroke | 2 years |
| Stroke | disabling and non-disabling stroke | 3 years |
| Stroke | disabling and non-disabling stroke | 4 years |
| Stroke | disabling and non-disabling stroke | 5 years |
| Repeat hospitalization | Number of hospitalizations | 1 month |
| Repeat hospitalization | Number of hospitalizations | 1 year |
| Repeat hospitalization | Number of hospitalizations | 2 years |
| Repeat hospitalization | Number of hospitalizations | 3 years |
| Repeat hospitalization | Number of hospitalizations | 4 years |
| Repeat hospitalization | Number of hospitalizations | 5 years |
| Bleeding | Life-threatening or major bleeding rate | 1 month |
| Bleeding | Life-threatening or major bleeding rate | 1 year |
| Bleeding | Life-threatening or major bleeding rate | 2 years |
| Bleeding | Life-threatening or major bleeding rate | 3 years |
| Bleeding | Life-threatening or major bleeding rate | 4 years |
| Bleeding | Life-threatening or major bleeding rate | 5 years |
| Vascular complication | Major vascular complication | 1 month |
| Vascular complication | Major vascular complication | 1 year |
| Vascular complication | Major vascular complication | 2 years |
| Vascular complication | Major vascular complication | 3 years |
| Vascular complication | Major vascular complication | 4 years |
| Vascular complication | Major vascular complication | 5 years |
| Acute kidney injury (stage 2 or 3) | 1 month |
| Acute kidney injury (stage 2 or 3) | 1 year |
| Acute kidney injury (stage 2 or 3) | 2 years |
| Acute kidney injury (stage 2 or 3) | 3 years |
| Acute kidney injury (stage 2 or 3) | 4 years |
| Acute kidney injury (stage 2 or 3) | 5 years |
| Prosthetic regurgitation by Doppler echocardiography | at discharge |
| Prosthetic regurgitation by Doppler echocardiography | 1 month |
| Prosthetic regurgitation by Doppler echocardiography | 1 year |
| Prosthetic regurgitation by Doppler echocardiography | 2 years |
| Prosthetic regurgitation by Doppler echocardiography | 3 years |
| Prosthetic regurgitation by Doppler echocardiography | 4 years |
| Prosthetic regurgitation by Doppler echocardiography | 5 years |
| Mean aortic valve gradient by Doppler echocardiography | 1 month |
| Mean aortic valve gradient by Doppler echocardiography | 1 year |
| Mean aortic valve gradient by Doppler echocardiography | 2 years |
| Mean aortic valve gradient by Doppler echocardiography | 3 years |
| Mean aortic valve gradient by Doppler echocardiography | 4 years |
| Mean aortic valve gradient by Doppler echocardiography | 5 years |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |