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HypertensionNCT02439775

SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System

A study testing Symplicity Spyral™ multi-electrode renal denervation system in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 56 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Symplicity Spyral™ multi-electrode renal denervation system
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
337 participants
Where
56 sitesin 10 countries
Study dates
22 Jul 2015to 14 Aug 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.
  • Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.

Who cannot join

  • Individual lacks appropriate renal artery anatomy.
  • Individual has estimated glomerular filtration rate (eGFR) of <45.
  • Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
  • Individual has one or more episodes of orthostatic hypotension.
  • Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
  • Individual has primary pulmonary hypertension.
Show all 10Show fewer
  • Individual is pregnant, nursing or planning to become pregnant.
  • Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment
  • Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
  • Individual works night shifts.

Trial locations and contacts

56 sites in 10 countries.

56 sites in 10 countries

United States32 sites

  • AnMed Health

    Anderson, South Carolina, 29621

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Baylor Heart & Vascular Hospital

    Dallas, Texas, 75226

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • PinnacleHealth Cardiovascular Institute

    Harrisburg, Pennsylvania, 17011

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

  • Memorial Hospital Jacksonville

    Jacksonville, Florida, 32216

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • Weill Cornell Medical College/The New York Presbyterian Hospital

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • St Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Oregon Health & Science University Hospital

    Portland, Oregon, 97239

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Providence Hospital

    Southfield, Michigan, 48075

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford Hospital and Clinics

    Stanford, California, 94305

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • Cardiology Associates Research LLC

    Tupelo, Mississippi, 38801

  • Washington DC VA Medical Center

    Washington D.C., District of Columbia, 20422

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

Other trials in United States

Germany5 sites

  • Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH

    Bad Krozingen, 79189

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Herzzentrum Leipzig, Universitätsklinik

    Leipzig, 04289

  • Sana Kliniken Lübeck

    Lübeck, 23560

Other trials in Germany

Japan5 sites

  • Mitsui Memorial Hospital

    Chiyoda City, Tokyo, 101-8643

  • Shonan Kamakura General Hospital

    Kamakura, Okamoto

  • Saiseikai Nakatsu Hospital

    Osaka

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

  • Higashi Takarazuka Satoh Hospital

    Takarazuka, Hyōgo

Other trials in Japan

United Kingdom4 sites

  • Royal Bournemouth Hospital

    Bournemouth

  • Cardiff and Vale University Health Board - University Hospital of Wales

    Cardiff

  • Royal Devon & Exeter NHS Foundation Trust

    Exeter, EX2 5DW

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

Other trials in United Kingdom

Australia3 sites

  • St. George Hospital

    Kogarah

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Perth

    Perth

Other trials in Australia

Canada2 sites

  • Hamilton Heath

    Hamilton, Ontario

  • St. Michael's Hospital

    Toronto, Ontario

Other trials in Canada

Greece2 sites

  • Hippokration General Hospital of Athens

    Athens, 11527

  • University General Hospital of Thessaloniki (AHEPA)

    Thessaloniki, 54621

Other trials in Greece

Austria1 site

  • Klinikum Wels-Grieskirchen

    Wels, 4600

Other trials in Austria

France1 site

  • Clinique Pasteur

    Toulouse

Other trials in France

Ireland1 site

  • Galway University Hospital

    Galway

Other trials in Ireland

About this study

Official title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.

Read the detailed description

The purpose of this study is to test the hypothesis that renal denervation is safe and reduces systolic blood pressure (SBP) in patients with uncontrolled hypertension on one, two, or three standard antihypertensive medications compared to a sham control in the same population. In this study, "uncontrolled hypertension" is defined as an office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg, an office Diastolic Blood Pressure (DBP) ≥90 mmHg and a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥140 mmHg to <170 mmHg, all of which are measured at Screening Visits. Data obtained will be used to confirm the effect of renal denervation on elevated blood pressure in patients on 1, 2 or 3 antihypertensive medications.

Being tested
Symplicity Spyral™ multi-electrode renal denervation system, Sham Procedure
Keywords
Uncontrolled hypertension, Renal denervation
Medical subject headings
Hypertension, Vascular Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Symplicity Spyral™ multi-electrode renal denervation systemDevice

    Also called Renal angiography, Renal Denervation

    After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

  • Sham ProcedureProcedure or surgery

    Also called Renal angiography

    After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Study groups in NCT02439775
Study groupRoleWhat they receive
Renal DenervationExperimentalRenal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Receives: Device: Symplicity Spyral™ multi-electrode renal denervation system
Sham ProcedureSham comparatorRenal angiography
Receives: Procedure: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

    Baseline adjusted change (using Analysis of Covariance) in systolic blood pressure (SBP) from baseline (Screening Visit 2) to 6 months post-procedure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

    Measured: From baseline to 6 months post-procedure

  2. Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events

    The Primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as composite of the following events: All-cause mortality, End stage renal Disease (ESRD), Significant embolic event resulting in end-organ damage, Renal artery perforation requiring intervention, Renal artery dissection requiring intervention, Vascular complications, Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol, New renal artery stenosis >70%, confirmed by angiography and as determined by the angiographic core laboratory, through one-month post-randomization (6-months for new renal artery stenosis)

    Measured: From Baseline to 1 month post-procedure (6 months for new renal artery stenosis)

Secondary outcomes (36)

  1. Change in Office Systolic Blood Pressure to 6-months

    Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure

    Measured: From baseline to 6 months post-procedure

  2. Antihypertensive Medication Usage and Changes to 6-months

    Number of medications from baseline (Screening Visit 2) through 6 Months post-procedure

    Measured: From baseline to 6-month post-procedure

  3. Antihypertensive Medication Burden to 6-months

    Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose.

    Minimum value 0; No Maximum value

    Measured: From baseline to 6 Months post-procedure

  4. Medication Changes

    Patients who had medication changes based on Medication Index 2 drug testing data. Medication Index 2 score is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency.

    Measured: Baseline to 6-months post-procedure

  5. Incidence of Achieving Target Office Systolic Blood Pressure

    Incidence of achieving target office systolic blood pressure (SBP<140 mmHg) at 6 months post- procedure.

    Measured: From baseline to 6 months post-procedure

  6. Change in Systolic Blood Pressure as Measured by 24-hour ABPM 12 Months

    Change in systolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

    Measured: From Baseline to 12 months post procedure

  7. Change in Systolic Blood Pressure as Measured by 24-hour ABPM 24-months

    Change in systolic blood pressure from baseline (screening visit 2) to 24 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

    Measured: From baseline to 24 months post-procedure

  8. Change in Systolic Blood Pressure as Measured by 24-hour ABPM 36-months

    Change in systolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

    Measured: From baseline to 36 months post-procedure

  9. Change in Office Systolic Blood Pressure to 12-months

    Change in office systolic blood pressure from baseline (screening visit 2) to 12 months.

    Measured: From Baseline to 12 months post procedure

  10. Change in Office Systolic Blood Pressure to 24-months

    Change in office systolic blood pressure from baseline (screening visit 2) to 24 months.

    Measured: From baseline to 24 months post-procedure

  11. Change in Office Systolic Blood Pressure to 36-months

    Change in office systolic blood pressure from baseline (screening visit 2) to 36 months.

    Measured: From baseline to 36 months post-procedure

  12. Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 12-months

    Change in diastolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

    Measured: From Baseline to 12 months post procedure

  13. Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 24-months

    Change in diastolic blood pressure from baseline (screening visit 2) to 24 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

    Measured: From baseline to 24 months post-procedure

  14. Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 36-months

    Change in diastolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

    Measured: From baseline to 36 months post-procedure

  15. Change in Office Diastolic Blood Pressure 12 Months

    Change in office diastolic blood pressure from baseline (screening visit 2) to 12 months.

    Measured: From baseline to 12 months post-procedure

  16. Change in Office Diastolic Blood Pressure 24 Months

    Change in office diastolic blood pressure from baseline (screening visit 2) to 24 months.

    Measured: From baseline to 24 months post-procedure

  17. Change in Office Diastolic Blood Pressure 36 Months

    Change in office diastolic blood pressure from baseline (screening visit 2) to 36 months.

    Measured: From baseline to 36 months post-procedure

  18. Number of Participants Achieving Target Office Systolic Blood Pressure 12 Months

    Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)

    Measured: From baseline to 12 months post-procedure

  19. Number of Participants Achieving Target Office Systolic Blood Pressure 24 Months

    Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg).

    Measured: From baseline to 24 months post-procedure

  20. Number of Participants Achieving Target Office Systolic Blood Pressure. 36 Months

    Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)

    Measured: From baseline to 36 months post-procedure

  21. Number of Participants With All Cause Mortality

    Measured: From Baseline to 36-months post procedure

  22. Number of Participants With End-Stage Renal Disease (ESRD)

    End-stage Renal Disease (ESRD) - defined as two or more eGFR measurements <15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

    • Volume management refractory to diuretics
    • Hyperkalemia unmanageable by diet and diuretics
    • Acidosis bicarbonate <18 unmanageable with HCO3 supplements
    • Symptoms of uremia, nausea, vomiting

    Measured: From Baseline to 36-months post-procedure

  23. Number of Participants With Significant Embolic Event Resulting in End-organ Damage

    Measured: From Baseline to 36 months post-procedure

  24. Number of Participants With Renal Artery Perforation Requiring Intervention

    Renal artery perforation requiring intervention

    Measured: From Baseline to 36 month post-procedure

  25. Number of Participants With Renal Artery Dissection Requiring Intervention

    Number of Participants with Renal artery dissection requiring intervention

    Measured: From Baseline to 36 months post-procedure

  26. Number of Participants With Vascular Complications

    Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24 hour period during the first 7 days post renal denervation procedure).

    Measured: From Baseline to 36 months post-procedure

  27. Number of Participants With Hospitalization for Hypertensive Crisis Not Related to Confirmed Non-adherence With Medications and/or the Protocol.

    Measured: From Baseline to 36 months post-procedure

  28. Number of Participants With New Renal Artery Stenosis > 70%, Confirmed by Angiography and as Determined by the Angiographic Core Laboratory

    Measured: From Baseline to 36 months post-procedure

  29. Number of Participants With ≥ 40% Decline in eGFR

    Measured: From baseline to 36 months post-procedure

  30. Number of Participants With Increase in Serum Creatinine >50% From Screening Visit 2 (Baseline)

    Measured: From baseline to 36 months post-procedure

  31. Number of Participants With New Myocardial Infarct

    Measured: From baseline to 36 months post-procedure

  32. Number of Participants With New Stroke

    Measured: From baseline to 36 months post-procedure

  33. Number of Participants With Renal Artery Re-intervention

    Measured: From baseline to 36 months post-procedure

  34. Number of Participants With Major Bleeding According to TIMI Definition

    Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure

    Measured: From baseline to 36 months post-procedure

  35. Change in Diastolic Blood Pressure as Measured by 24-hour (ABPM) 6-months

    Change in diastolic blood pressure from baseline (screening visit 2) to 6 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

    Measured: From baseline to 6 months post-procedure

  36. Change in Office Diastolic Blood Pressure to 6-months

    Change in office diastolic blood pressure from baseline (screening visit 2) to 6 months post-procedure

    Measured: From baseline to 6 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study start22 Jul 2015
  3. Primary completion18 Aug 2022
  4. Study completion14 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
337 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02439775
Sponsor's protocol ID
SPYRAL HTN-ON MED
Status last verified
Jul 2026
First submitted
28 Apr 2015
Last updated
30 Jul 2026
Data monitoring committee
Yes
FDA-regulated device
Yes

Publications

  • Kandzari DE, Mahfoud F, Townsend RR, Kario K, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Yang G, Brar S, Bohm M. Three-Year Durability of Radiofrequency Renal Denervation: SPYRAL HTN-ON MED. J Am Heart Assoc. 2026 Jun 16;15(12):e049081. doi: 10.1161/JAHA.126.049081. Epub 2026 Jun 15.

    PubMed 42294771

  • Kandzari DE, Mahfoud F, Townsend RR, Kario K, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Liu M, DeBruin V, Brar S, Bohm M. Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial. Circ Cardiovasc Interv. 2025 Jul;18(7):e015194. doi: 10.1161/CIRCINTERVENTIONS.125.015194. Epub 2025 May 20.

    PubMed 40391448

  • Bytyqi V, Kannenkeril D, Striepe K, Bosch A, Karg MV, Schmid A, Schiffer M, Uder M, Schmieder RE. Predicting blood pressure response to renal denervation based on a new approach. J Hypertens. 2025 Mar 1;43(3):413-419. doi: 10.1097/HJH.0000000000003918. Epub 2024 Oct 29.

    PubMed 39526682

  • Townsend RR, Ferdinand KC, Kandzari DE, Kario K, Mahfoud F, Weber MA, Schmieder RE, Pocock S, Tsioufis K, David S, Steigerwalt S, Walton A, Hopper I, Bertolet B, Sharif F, Fengler K, Fahy M, Hettrick DA, Brar S, Bohm M. Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED. Hypertension. 2024 May;81(5):1095-1105. doi: 10.1161/HYPERTENSIONAHA.123.22251. Epub 2024 Feb 5.

    PubMed 38314554

  • Kandzari DE, Townsend RR, Kario K, Mahfoud F, Weber MA, Schmieder RE, Pocock S, Tsioufis K, Konstantinidis D, Choi J, East C, Lauder L, Cohen DL, Kobayashi T, Schmid A, Lee DP, Ma A, Weil J, Agdirlioglu T, Schlaich MP, Shetty S, Devireddy CM, Lea J, Aoki J, Sharp ASP, Anderson R, Fahy M, DeBruin V, Brar S, Bohm M; SPYRAL HTN-ON MED Investigators. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. 2023 Nov 7;82(19):1809-1823. doi: 10.1016/j.jacc.2023.08.045.

    PubMed 37914510

  • Mahfoud F, Kandzari DE, Kario K, Townsend RR, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Dimitriadis K, Choi JW, East C, D'Souza R, Sharp ASP, Ewen S, Walton A, Hopper I, Brar S, McKenna P, Fahy M, Bohm M. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. Lancet. 2022 Apr 9;399(10333):1401-1410. doi: 10.1016/S0140-6736(22)00455-X. Epub 2022 Apr 4.

    PubMed 35390320

  • Kandzari DE, Hickey GL, Pocock SJ, Weber MA, Bohm M, Cohen SA, Fahy M, Lamberti G, Mahfoud F. Prioritised endpoints for device-based hypertension trials: the win ratio methodology. EuroIntervention. 2021 Apr 2;16(18):e1496-e1502. doi: 10.4244/EIJ-D-20-01090.

    PubMed 33226002

  • Kario K, Weber MA, Bohm M, Townsend RR, Mahfoud F, Schmieder RE, Tsioufis K, Cohen SA, Fahy M, Kandzari DE. Effect of renal denervation in attenuating the stress of morning surge in blood pressure: post-hoc analysis from the SPYRAL HTN-ON MED trial. Clin Res Cardiol. 2021 May;110(5):725-731. doi: 10.1007/s00392-020-01718-6. Epub 2020 Aug 1.

    PubMed 32740754

  • Bohm M, Townsend RR, Kario K, Kandzari D, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Hickey GL, Fahy M, DeBruin V, Brar S, Pocock S. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol. 2020 Mar;109(3):289-302. doi: 10.1007/s00392-020-01595-z. Epub 2020 Feb 7.

    PubMed 32034481

  • Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.

    PubMed 29803589

  • Kandzari DE, Kario K, Mahfoud F, Cohen SA, Pilcher G, Pocock S, Townsend R, Weber MA, Bohm M. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91. doi: 10.1016/j.ahj.2015.08.021. Epub 2015 Sep 11.

    PubMed 26699604

Questions about this trial

What is this clinical trial studying?

A study testing Symplicity Spyral™ multi-electrode renal denervation system in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 56 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Germany, Japan, United Kingdom, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) (time frame: From baseline to 6 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02439775, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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