Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05198674 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

NCT05198674 · ClinicalTrials.gov record · last posted 2026-08-25

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

Name: SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN — clinical trial record (NCT05198674)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusActive, Not Recruiting

PhaseNot applicable

SponsorMedtronic Vascular

Started2021-10-20

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-18

Primary completion moved earlier: 2026-11-30 → 2026-03-05

2026-04-23

Enrollment increased: 1300 → 1899 participants

Trial Details

NCT Number	NCT05198674
Lead Sponsor	Medtronic Vascular
Conditions	Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus
Enrollment	1,899 participants
Start Date	2021-10-20
Primary Completion	2026-03-05 (estimated)
Study Completion	2029-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-25