The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)
Objective
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation.
Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.
Study Arms
- Experimental: Main Cohort: Renal Denervation
Eligibility
- Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg.
- Individual has a baseline office diastolic blood pressure ≥ 90 mmHg.
- Individual has an average systolic baseline home blood pressure ≥135 mmHg.
NCT ID
NCT05198674
