An interventional study of Renal Denervation (Symplicity Spyral™) in Hypertension, Vascular Diseases and Cardiovascular Diseases, sponsored by Medtronic Vascular. Active, not recruiting at 97 sites in 11 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 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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 1,899 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.
Counted across the registry records on this site, refreshed daily.
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: 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.
Also known as: Renal Angiography, Renal Denervation
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months will be assessed for all patients in the Main Study Cohort
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 (Main Cohort Only)
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 EQ-5D quality of life score
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
Evaluate pre-specified subgroups (Chronic Kidney Disease, Diabetes Mellitus Type II, etc) as predictors for change in blood pressure as measured by OBP, HBP and ABPM
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 events, including major adverse events
Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Ran from Oct 2021 to primary completion in Mar 2026, 52 months.
Of 95 industry-sponsored interventional studies with no phase under Hypertension, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's 52 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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