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Tests a streamlined kidney nerve procedure for uncontrolled high blood pressure

Tests a faster kidney nerve procedure in adults with uncontrolled high blood pressure.

Key facts

Who runs it
Medtronic Vascular
Where
Dublin, IrelandSee the siteAlso in 8 other countries, 20 sites
Trial code
Registry title
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Status
Recruiting
People taking part
130 people, planned
Started
22 Sept 2025
Expected to end
30 Apr 2030
Type of study
Interventional
Treatments tested
  • Symplicity Spyral™ multi-electrode renal denervation system
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with high blood pressure that is not under control. They would have a procedure called renal denervation with the Symplicity Spyral system.

Age
18 years or older
Sex
All sexes can join
Disease stage
Diagnosed hypertension with office blood pressure of 140 mmHg or more (top number) and 90 mmHg or more (bottom number). Average home blood pressure (top number) is 135 mmHg or more. A valid 24-hour blood pressure measurement is needed.
Earlier treatment
People who have had renal denervation before cannot join.

Main reasons for not taking part

  • Kidney arteries are not the right shape for the procedure
  • Had renal denervation before
  • eGFR (a kidney function test) below 45 mL/min/1.73m2
  • Pregnant, nursing or planning to become pregnant
  • Type 1 diabetes, or type 2 diabetes with glycosylated hemoglobin above 8.0%

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
  • Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
  • Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre-procedure measurements)
  • Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline

Who cannot take part

  • Individual has undergone prior renal denervation
  • Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
  • Individual has documented primary pulmonary hypertension
  • Individual has an estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73m2
  • Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
  • Individual lacks appropriate renal artery anatomy
  • Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
  • Individual has one or more episode(s) of orthostatic hypotension
  • Individual is pregnant, nursing or planning to become pregnant

Where in Ireland

Also in 8 other countries, 20 sites

  • Mater Misericordiae University HospitalDublin, IrelandContact: Adela Martinez SanchezNo longer taking part

About the trial

What the trial wants to find out

The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.

The group in the trial

  • SWYFT cohortTreatment being tested

    Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

    Treatment: Symplicity Spyral™ multi-electrode renal denervation system

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)
Plain-language title
Tests a streamlined kidney nerve procedure for uncontrolled high blood pressureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
16 October 2026