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.
Who Can Participate?
Eligibility
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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
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
Symplicity Spyral Renal Denervation System in Subjects with Uncontrolled
Hypertension
Principal Investigator
Manesh
Patel
Protocol Number
PRO00112953
NCT ID
NCT05198674
Phase
III
Enrollment Status
Open to Enrollment