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

NCT05198674 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1899

Last updated 2026-05-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Principal Investigators

  • David Kandzari, MD · Piedmont Heart Institute

  • Felix Mahfoud, MD · Saarland University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2026-11-30
Completion
2029-11-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Germany
  • Greece
  • Ireland
  • Monaco
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05198674 on ClinicalTrials.gov