Status:
UNKNOWN
CoreValve Evolut Pro Prospective Registry
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
Medtronic Cardiovascular
Conditions:
Aortic Stenosis
Eligibility:
All Genders
50+ years
Brief Summary
The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registr...
Detailed Description
The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and ...
Eligibility Criteria
Inclusion
- Symptomatic severe aortic stenosis
- Intermediate, high or extreme surgical risk
- The institutional Heart Team determines that transcatheter aortic valve replacement with an Evolut Pro device is appropriate
Exclusion
- Subject unable or unwilling to give informed consent
- For subjects in the CT arm only, renal function precluding the administration of iodinated contrast for cardiac CT (eGFR \< 30 ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media.
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Key Trial Info
Start Date :
January 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03423459
Start Date
January 18 2018
End Date
December 31 2024
Last Update
May 26 2023
Active Locations (2)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
Medstar Union Memorial Hospital
Baltimore, Maryland, United States, 21218