Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2016
CompletedFirst Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2028
February 11, 2019
February 1, 2019
12 years
February 7, 2019
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (6)
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
Secondary Outcomes (49)
Death from cardiac cause
1 month
Death from cardiac cause
1 year
Death from cardiac cause
2 years
Death from cardiac cause
3 years
Death from cardiac cause
4 years
- +44 more secondary outcomes
Interventions
Eligibility Criteria
All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
You may qualify if:
- Age≥18 years.
- Severe aortic stenosis with bicuspid anatomy.
- NYHA≥2 and/or syncope and/or angina.
- Patient judged by the Heart Team as indicated for TAVR.
You may not qualify if:
- Age \<18 years
- Asymptomatic patients
- Pure aortic regurgitation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Related Publications (1)
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.
PMID: 32854836DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Profssor of Medicine, University of California
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 11, 2019
Study Start
August 15, 2016
Primary Completion (Estimated)
August 15, 2028
Study Completion (Estimated)
August 15, 2028
Last Updated
February 11, 2019
Record last verified: 2019-02