An interventional study of Symplicity Spyral™ multi-electrode renal denervation system in Hypertension, Vascular Diseases and Cardiovascular Diseases, sponsored by Medtronic Vascular. Recruiting at 21 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Medtronic Vascular (part of Medtronic) · Not applicable, Interventional, and Treatment
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 130 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Medtronic Vascular is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Device: Symplicity Spyral™ multi-electrode renal denervation system
After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Also known as: Renal Angiography, Renal Denervation
Procedure time
Procedure time will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED procedure times.
Time frame: Procedure
Office Systolic Blood Pressure Change
Office Systolic Blood Pressure (OSBP) change from baseline to 6 months will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED study efficacy endpoints using a propensity score stratified baseline blood pressure adjusted analysis at 3 months (OFF MED) and 6 months (ON MED).
Time frame: 6 months
Office Systolic Blood Pressure change
Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Home Blood Pressure change
Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Change in blood pressure as measured by 24-hour ABPM
Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM
Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Time subject's blood pressure is controlled
Time frame: Procedure to 36 months post-procedure
Change in number of anti-hypertensive medications taken from baseline
Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Change from baseline in hypertension health status score
Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure. A higher score means a better outcome.
Evaluate factors influencing blood pressure response to renal denervation
Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Evaluation of slope of eGFR
Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Incidence of safety events, including major adverse events
Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
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Plan to share: No — There is no plan to share individual participant data. Aggregate results will be made publicly available via publications and conference presentations.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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