CoreValve Evolut Pro Prospective Registry

Status unconfirmed

Conditions studied: Aortic Stenosis

In brief

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 registry.

Key facts

Study ID

NCT03423459

Run by

Medstar Health Research Institute

People needed

200

Starts

2018-01-18

Expected to finish

2024-12-31

Last updated by the study team

2023-05-26

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Medstar Union Memorial Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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