This clinical trial is for men and women age 18 and older who have severe aortic valve stenosis and are scheduled to undergo a Transcatheter Aortic Valve Replacement procedure ("TAVR," also known as Transcatheter Aortic Valve Implantation or "TAVI").
The purpose of the study is to evaluate the safety and efficacy of the Sentinel™ Cerebral Protection System made by Claret Medical, Inc. The Sentinel system is intended to capture and remove blood clots that may form during a TAVR procedure so as to protect the brain from possible damage due to blockage of the arteries that supply blood to the brain.
Study subjects will be followed up for 90 days after the TAVR procedure.
Men and women age 18 and older who are diagnosed with severe symptomatic calcified native aortic valve stenosis (narrowing) and are scheduled to undergo a Transcatheter Aortic Valve Replacement procedure ("TAVR," also known as Transcatheter Aortic Valve Implantation or "TAVI") may enroll in the study.
Detailed eligibility requirements will be reviewed when you contact the study team.
Dolores Reynolds, R.N., phone 212-746-4617, email email@example.com
Cerebral Protection in Transcatheter Aortic Valve Replacement: The SENTINEL Study. ClinicalTrials.gov Identifier NCT02214277