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ARTIST Trial for Patients with Aortic Regurgitation (AR)
Protocol: STUDY00009874
Full Title
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy(TM) Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation
Description
Have you been diagnosed with aortic regurgitation (AR)? If so, you may be eligible for the ARTIST clinical trial.

AR is a serious disease that affects about 2.7 million people in the US. It limits your heart’s ability to pump blood. This can potentially impact your quality of life. The purpose of the ARTIST trial is to learn if a new device works to help treat AR.

This study will last for 10 years. Participants will be randomly assigned (which happens by chance, like flipping a coin) to one of the following groups:

-Group 1 will have the study device placed in through an artery in their groin
-Group 2 will have surgery to replace their aortic valve

Participants will have check-ups with their doctor following their procedures at 1 month, 6 months, 1 year, and yearly for 10 years. They will have physical exams, blood work, surveys, walking tests, and imaging tests.

Participants will be paid $50 for each study visit.
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
Adults 18 years or older
Have been diagnosed with moderate to severe aortic regurgitation (AR)
Age Group: Adults
Principal Investigator: VIJAY IYER
ClinicalTrials.gov: Open Study
Contact(s)
DAWN HOLLER
dlh68@buffalo.edu
+1 716-829-6115
COURTNEY BISHOP
cabishop@buffalo.edu
+1 716-888-4859

Want to Learn More?

Let us know how the study team can reach you. If you do not hear back within 2 business days, then reach out to the study team directly at the contact information above and someone will assist you.

Your information will be shared only with the research study team and administrative staff for recruitment and will remain confidential. Your information will be stored until study recruitment is closed. Should you no longer want this information to be provided in the aforementioned ways, please contact the study team directly.

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