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Evaluating the Symplicity Spyral system for treating uncontrolled hypertension

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

Not applicable Interventional Medtronic Vascular · NCT05198674

This study is testing a new device to see if it can safely help people with high blood pressure that isn't controlled by medication.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1400 (estimated)
Ages18 Years and up
SexAll
SponsorMedtronic Vascular Industry-sponsored
Locations99 sites (Birmingham, Alabama and 98 other locations)
Trial IDNCT05198674 on ClinicalTrials.gov

What this trial studies

This interventional study aims to assess the long-term safety, efficacy, and durability of the Symplicity Spyral renal denervation system in patients with uncontrolled hypertension. Participants will undergo renal denervation, and long-term follow-up data will be collected from those previously treated in related studies. The study focuses on individuals with specific blood pressure criteria to determine the effectiveness of this treatment approach.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with hypertension who have specific elevated blood pressure measurements.

Not a fit: Patients with certain renal artery anatomy issues or those who have undergone prior renal denervation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with uncontrolled hypertension.

How similar studies have performed: Previous studies involving renal denervation have shown promising results, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

Exclusion Criteria:

1. Individual lacks appropriate renal artery anatomy
2. Individual has undergone prior renal denervation
3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
5. Individual has an estimated glomerular filtration rate (eGFR) of \<45
6. Individual has one or more episode(s) of orthostatic hypotension
7. Individual is pregnant, nursing or planning to become pregnant
8. Individual has primary pulmonary hypertension
9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%

Where this trial is running

Birmingham, Alabama and 98 other locations

+49 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HypertensionVascular DiseasesCardiovascular DiseasesChronic Kidney DiseasesDiabetes Mellitus
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.