SPYRAL AFFIRM (Uncontrolled Hypertension) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental medical device is helpful for people who have hypertension (high blood pressure) that is not adequately controlled by medicine. The study device is designed to cause disruption to certain nerves in the kidneys. We want to know if disrupting these nerves (called "renal denervation") can lower people's blood pressure without adding more medication to their regimen.
What is the Condition Being Studied?
Uncontrolled Hypertension
Who Can Participate in the Study?
People ages 18+ who are diagnosed with uncontrolled, malignant, or resistant hypertension.
For more information, contact the study team at oksana.zakharova@duke.edu.
Age Group
Adults
What is Involved?
If you choose to join this study, you will:
- Have a renal denervation procedure done within 30 days of your first study visit after we confirm that you are eligible to continue in the study
- Continue to take your normal blood pressure medications without any changes for at least 6 months after the procedure
- Visit our clinic at least 5 times after the procedure for physical exams and to have tests done
Study Details
Full Title
The SPYRAL AFFIRM Global Clinical Study of Renal Denervation with the
Symplicity Spyral Renal Denervation System in Subjects with Uncontrolled
Hypertension
Principal Investigator
Cardiologist
Protocol Number
IRB:
PRO00112953
NCT:
NCT05198674
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment