Sentinel Low Risk Registry

Completed

Conditions studied: Aortic Valve Stenosis

In brief

This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.

Key facts

Study ID

NCT04131127

Run by

CVPath Institute Inc.

People needed

50

Starts

2020-01-07

Expected to finish

2020-08-19

Last updated by the study team

2020-10-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Columbia University Medical Center — New York, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UPMC Pinnacle — Wormleysburg, Pennsylvania, United States

Full record on ClinicalTrials.gov

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