Status:
COMPLETED
Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Native and Valve in Valve Aortic Valve Failure
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Background: TAVR is a common therapy for people with heart problems. It stands for transcatheter aortic valve replacement, TAVR can be a better option than surgery. But it isn t safe for everyone. It...
Detailed Description
Transcatheter aortic valve replacement (TAVR) is an option to treat aortic valve stenosis or failure of a surgically implanted tissue valve. Sometimes TAVR displaces the diseased aortic valve leaflets...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adults age greater than or equal to 21 years
- High or extreme risk of surgical aortic valve replacement according to the local multidisciplinary heart team
- Undergoing TAVR for valve-in-valve or native aortic valve failure ( on-label TAVR)
- Deemed likely to suffer coronary artery obstruction from TAVR according to multidisciplinary heart team
- Concurrence of the study eligibility committee
- EXCLUSION CRITERIA:
- Subjects unable to consent to participate, unless the subject has a legally authorized representative
- Excessive target aortic leaflet calcification or masses on baseline CT
- Survival despite successful procedure expected \< 12 months
- Planned concurrent valve intervention in the same setting (such as transcatheter mitral valve therapy or paravalvular leak therapy)
- Subjects unwilling to participate or unwilling to return for study follow-up activities.
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Exclusion
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03381989
Start Date
February 14 2018
End Date
August 22 2019
Last Update
March 18 2021
Active Locations (4)
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1
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Henry Ford Hospital
Detroit, Michigan, United States, 48202
4
University of Washington
Seattle, Washington, United States, 98195