SPYRAL AFFIRM

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

1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg.
2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg.
3. Individual has an average systolic baseline home blood pressure ≥135 mmHg.
    

NCT ID

NCT05198674