At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Symplicity Spyral™ multi-electrode renal denervation system (device)
- How long the study runs
- Study runs about 51 months (dates as stated)
- About the drug or intervention
- Symplicity Spyral™ multi-electrode renal denervation system — device: After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called SPYRAL SWYFT, is looking at a treatment called renal denervation for people with uncontrolled high blood pressure (hypertension). The treatment is described as 'streamlined denervation', which uses a device to target nerves near the kidney arteries. The study is funded by Medtronic Vascular. Whether the treatment works or how it is done is Not stated — ask the trial team.
Who can take part
- You have high blood pressure with a clinic (office) top number of 140 mmHg or higher.
- Your clinic bottom number is 90 mmHg or higher.
- Your home blood pressure readings, taken over at least 7 days, average 135 mmHg or higher for the top number.
- You have a valid 24-hour blood pressure monitor reading taken before any procedure.
Who may not be able to
- The arteries to your kidneys are not the right shape for the treatment.
- You have had renal denervation before.
- You have a condition that makes it hard to measure your blood pressure accurately.
- You need oxygen or a ventilator during the day (night-time support for sleep apnoea is allowed).
- Your kidney function (eGFR) is below 45 mL/min/1.73m².
- You have had episodes of low blood pressure when standing up.
- You are pregnant, breastfeeding, or planning to become pregnant.
- You have pulmonary hypertension (high blood pressure in the lungs).
- You have type 1 diabetes, or type 2 diabetes that is not well controlled (HbA1c above 8.0%).
What taking part involves
- • Not stated — ask the trial team.
Time commitment: Number of visits, study length and what taking part involves are Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 130
- Started
- 2025-09-22
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for hypertension
- • NA - 130 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hypertension
Where?
- • Oxford - Oxford University Hospitals NHS Trust - John Radcliffe Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
SPYRAL SWYFT will evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system to determine whether renal denervation 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 (where all accessible renal arterial vessels between 3 and 8 mm in diameter including accessory, branch and main renal arteries (outside the kidney parenchyma) were targeted for ablation). SPYRAL SWYFT study is conducted under the overarching SPYRAL AFFIRM protocol (NCT05198674), focused on EU and APAC regions.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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...
- ✓Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline
Who cannot take part
- ✗Individual lacks appropriate kidney artery anatomy
- ✗Individual has undergone prior kidney denervation
- ✗Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood...
- ✗Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for...
- ✗Individual has an estimated glomerular filtration rate (eGFR) of \<45 mL/min/1.73m2
See the full criteria
Where Is This Study? (1 UK site)
Oxford University Hospitals NHS Trust - John Radcliffe Hospital
Oxford, United Kingdom
How to Get in Touch
Kelsey Anderson
Sponsor contactCONTACT
Carly Loudoun
Sponsor contactCONTACT