Status:
COMPLETED
Sentinel Low Risk Registry
Lead Sponsor:
CVPath Institute Inc.
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
Brief Summary
This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.
Detailed Description
The SENTINEL-LIR Study is a multicenter, prospective registry to observe rate and type of debris capture in subjects at low surgical risk undergoing TAVI to demonstrate the positive effects of the use...
Eligibility Criteria
Inclusion
- Severe symptomatic aortic valve stenosis
- Planned use of Sentinel System
- Subject planned for transfemoral TAVI with valve system approved by U.S. FDA for low risk patients
- STS-PROM score of less than 4% and agreement by Heart Team that patients meet criteria for low surgical risk
Exclusion
- Current or recent cerebrovascular accident (stroke, TIA) \<6 months
- Transapical, direct aortic or subclavian TAVI access
- Carotid stenting or endarterectomy in last 6 weeks
- Prior aortic valve replacement
- Concomitant procedure with TAVI such as CABG, PCI, etc.
Key Trial Info
Start Date :
January 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 19 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04131127
Start Date
January 7 2020
End Date
August 19 2020
Last Update
October 19 2020
Active Locations (4)
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1
Columbia University Medical Center
New York, New York, United States, 10032
2
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
UPMC Pinnacle
Wormleysburg, Pennsylvania, United States, 17043