Active Not Recruiting INTERVENTIONAL 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)

Sponsor: Medtronic Vascular

Conditions Cardiovascular Diseases Chronic Kidney Diseases Diabetes Mellitus Hypertension Vascular Diseases

Interventions Renal Denervation (Symplicity Spyral™)

Updated 41 times since 2022 Last updated: Apr 17, 2026 Started: Oct 20, 2021 Primary completion: Nov 30, 2026 Completion: Nov 30, 2029

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Cardiovascular Diseases and Chronic Kidney Diseases, this trial is ongoing. The trial is conducted by Medtronic Vascular and has accumulated 41 data snapshots since 2021. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Status Flow

Change History

41 versions recorded

Apr 23, 2026 — Present [daily]

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First recorded

Oct 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:

Medtronic Vascular

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aalst, Belgium , Anderson, United States , Ann Arbor, United States , Athens, Greece , Atlanta, United States , Atlanta, United States , Aurora, United States , Baltimore, United States , Birmingham, United States , Bordeaux, France and 90 more locations