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US GPS Trial for Adults with High Blood Pressure
Protocol: STUDY00008997
Full Title
The Global Paradise System US Post Approval Study (US GPS)
Description
High blood pressure (BP) is a common condition that affects many adults. It causes your heart to have to work harder to pump blood throughout your body. If left untreated, it can lead to damage of blood vessels and the heart over time. This can lead to heart attack or stroke. Unfortunately, it can be challenging for adults to manage their high BP despite making lifestyle changes and taking medications.

The US Global Paradise System (GPS) study is designed to see if the Paradise system can help to lower BP in patients who are struggling to control their high BP. This study will last for 5 years. Eligible participants will have a physical exam, have their BP measured, and provide blood and urine samples. They will record their BP at home for 7 days. Then they will have a procedure to treat with the Paradise system.

Participants will complete in-person study visits at 1, 3 and 12 months. They will measure and record their BP at home for 7 days before each visit. They will also complete phone interviews at 6 months, 2, 3, 4 and 5 years. After 12 months, they will measure and record their BP at home every 3. They will share this information with the study team.
Compensation: No
Eligibility
Adults 18 years or older
Have been diagnosed with high blood pressure (hypertension)
Are struggling to control their high blood pressure despite taking medication and attempting lifestyle changes
Age Group: Adults
Principal Investigator: VIJAY IYER
ClinicalTrials.gov: Open Study
Contact(s)
DAWN HOLLER
dlh68@buffalo.edu
+1 716-829-6115

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