Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement.
Sung-Han Yoon, Won-Keun Kim, Abhijeet Dhoble...
https://pubmed.ncbi.nlm.nih.gov/32854836Actively Recruiting
Age: 19Years - 129Years
All Genders
ID03836521
The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
Led by Cedars-Sinai Medical Center · Updated on 2019-02-11
2000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing patients with bicuspid aortic valve stenosis to understand the outcomes of those undergoing transcatheter aortic valve replacement (TAVR). This study aims to evaluate both procedural success and clinical results over time in this patient group. The research is sponsored by Cedars-Sinai Medical Center and focuses on adults diagnosed with severe aortic stenosis and bicuspid valve anatomy who require this intervention. The study involves monitoring patients who have undergone TAVR, a procedure where a device is used to replace the aortic valve through a catheter without open-heart surgery. Participants are selected based on specific clinical criteria, including symptom severity and heart team assessment. This registry does not involve assigning treatments but collects data from patients receiving TAVR as part of their care. Participants will be followed to observe outcomes such as death at multiple time points up to five years after the procedure. Additional measurements include cardiac-related deaths, stroke, hospital readmissions, bleeding, vascular complications, kidney injury, and valve function assessed by echocardiography at discharge and various intervals. The study gathers detailed information to better understand long-term patient results and safety after TAVR in bicuspid aortic valve stenosis.
CONDITIONS
Brief Title
Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
Who Can Participate
Age: 19Years - 129Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Severe aortic stenosis with bicuspid valve anatomy
- New York Heart Association class 2 or higher and/or syncope and/or angina
- Patient evaluated and recommended for transcatheter aortic valve replacement by Heart Team
You will not qualify if you...
- Age younger than 18 years
- Asymptomatic patients
- Pure aortic regurgitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - 1 day
Participants undergo transcatheter aortic valve replacement.
1 visit (in-person)
Post-operative Follow-up
Duration - Up to 5 years
Participants are monitored for health outcomes and potential complications after the valve replacement.
Multiple visits over 5 years
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
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Research Team
S
Sung-Han Yoon, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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