Status:
COMPLETED
Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
21-99 years
Phase:
PHASE1
Brief Summary
Background: \- Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that are too small and are too sick for standard techniques. But they may benefit from a new tech...
Detailed Description
Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) has enabled transcatheter aortic valve replacement (TAVR) in a small number of patients who have no good options ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adults age greater than or equal to 21 years
- Severe symptomatic de novo aortic valve stenosis or bioprosthetic aortic valve failure for which transcatheter aortic valve replacement (TAVR) is felt beneficial according to the consensus of the institutional multidisciplinary heart team
- Extreme risk or inoperability for TAVR via conventional femoral artery, trans-apical, or trans-aortic access in the determination of the multidisciplinary heart team. This determination includes an in-person consultation by at least one cardiac surgeon member of the heart team.
- Anatomic eligibility for caval-aortic TAVR, graded as favorable or feasible based on NHLBI core lab assessment of the baseline CT examination.
- EXCLUSION CRITERIA:
- Unable or unwilling to consent to participate
- Anatomic eligibility for caval-aortic TAVR graded as unfavorable based on NHLBI core lab assessment of the baseline CT examination
- Unlikely to benefit from caval-aortic TAVR
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements.
Exclusion
Key Trial Info
Start Date :
October 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2018
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT02280824
Start Date
October 30 2014
End Date
December 28 2018
Last Update
February 15 2019
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
Emory University
Atlanta, Georgia, United States, 30322-1102
3
NorthShore University HealthSystem, Evanston Hospital
Evanston, Illinois, United States, 60201
4
Advocate Heart Institute
Oakbrook Terrace, Illinois, United States, 60181