NCT05198674

SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypertension
• Vascular Diseases
• Cardiovascular Diseases
• Chronic Kidney Diseases
• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Renal Denervation (Symplicity Spyral™)	Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.

Timeline

• Start date: 2021-10-20
• Primary completion: 2026-11-30
• Completion: 2029-11-30
• First posted: 2022-01-20
• Last updated: 2026-03-20

Locations

100 sites across 11 countries: United States, Australia, Belgium, France, Germany, Greece, Ireland, Monaco, Netherlands, Sweden, United Kingdom

Regulatory

• FDA-regulated device study