Bicuspid Aortic Valve
Conditions
Brief summary
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.
Interventions
DEVICETranscatheter aortic valve replacement
Sponsors
Cedars-Sinai Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 129 Years
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years. 2. Severe aortic stenosis with bicuspid anatomy. 3. NYHA≥2 and/or syncope and/or angina. 4. Patient judged by the Heart Team as indicated for TAVR.
Exclusion criteria
1. Age \<18 years 2. Asymptomatic patients 3. Pure aortic regurgitation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | 1 month | Death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death from cardiac cause | 1 month | Death from cardiac cause |
| Stroke | 1 month | disabling and non-disabling stroke |
| Repeat hospitalization | 1 month | Number of hospitalizations |
| Bleeding | 1 month | Life-threatening or major bleeding rate |
| Vascular complication | 1 month | Major vascular complication |
| Acute kidney injury (stage 2 or 3) | 1 month | — |
| Prosthetic regurgitation by Doppler echocardiography | at discharge | — |
| Mean aortic valve gradient by Doppler echocardiography | 1 month | — |
Countries
United States
Contacts
Primary ContactSung-Han Yoon, M.D.
Outcome results
None listed