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

October 30, 2025 updated by: Medtronic Vascular

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

337

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Kogarah, Australia
        • St. George Hospital
      • Perth, Australia
        • Royal Perth
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
  • Austria
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Heath
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
  • France
      • Toulouse, France
        • Clinique Pasteur
  • Germany
      • Bad Krozingen, Germany, 79189
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
      • Homburg, Germany, 66421
        • Universitätsklinikum des Saarlandes
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig, Universitätsklinik
      • Lübeck, Germany, 23560
        • Sana Kliniken Lubeck
  • Greece
      • Athens, Greece, 11527
        • Hippokration General Hospital of Athens
      • Thessaloniki, Greece, 54621
        • University General Hospital of Thessaloniki (AHEPA)
  • Ireland
      • Galway, Ireland
        • Galway University Hospital
  • Japan
      • Osaka, Japan
        • Saiseikai Nakatsu Hospital
    • Hyōgo
      • Takarazuka, Hyōgo, Japan
        • Higashi Takarazuka Satoh Hospital
    • Okamoto
      • Kamakura, Okamoto, Japan
        • Shonan Kamakura General Hospital
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
    • Tokyo
      • Chiyoda City, Tokyo, Japan, 101-8643
        • Mitsui Memorial Hospital
  • United Kingdom
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital
      • Cardiff, United Kingdom
        • Cardiff and Vale University Health Board - University Hospital of Wales
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon & Exeter NHS Foundation Trust
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC
    • California
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale New Haven Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20422
        • Washington DC VA Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center Jacksonville
      • Jacksonville, Florida, United States, 32216
        • Memorial Hospital Jacksonville
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Michigan
      • Pontiac, Michigan, United States, 48341
        • St Joseph Mercy Oakland
      • Southfield, Michigan, United States, 48075
        • Providence Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic
      • Tupelo, Mississippi, United States, 38801
        • Cardiology Associates Research LLC
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical College/The New York Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University Hospital
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17011
        • PinnacleHealth Cardiovascular Institute
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Heart & Vascular Hospital
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal Denervation
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 remain blinded and are immediately treated with the renal denervation procedure after randomization.
Other Names:
  • Renal angiography
  • Renal Denervation
Sham Comparator: Sham Procedure
Renal angiography
Procedure: Sham Procedure
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.
Other Names:
  • Renal angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Time Frame: From baseline to 1 month post-procedure (6 months for new renal artery stenosis)
The primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as a 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 a determined by the angiographic core laboratory, through one-month post-randomization (6- months for new renal artery stenosis).
From baseline to 1 month post-procedure (6 months for new renal artery stenosis)
Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Time Frame: From baseline to 6 months post-procedure
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).
From baseline to 6 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antihypertensive Medication Usage and Changes to 6-months
Time Frame: From baseline to 6-month post-procedure
Number of medications from baseline (Screening Visit 2) through 6 Months post-procedure
From baseline to 6-month post-procedure
Antihypertensive Medication Burden to 6-months
Time Frame: From baseline to 6 Months post-procedure

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
From baseline to 6 Months post-procedure
Medication Changes
Time Frame: Baseline to 6-months post-procedure
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.
Baseline to 6-months post-procedure
Incidence of Achieving Target Office Systolic Blood Pressure
Time Frame: From baseline to 6 months post-procedure
Incidence of achieving target office systolic blood pressure (SBP<140 mmHg) at 6 months post- procedure.
From baseline to 6 months post-procedure
Change in Office Systolic Blood Pressure
Time Frame: From baseline to 6 months post-procedure
Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure
From baseline to 6 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Vascular

Investigators

  • Principal Investigator: Raymond Townsend, MD, University of Pennsylvania
  • Principal Investigator: David Kandzari, MD, Piedmont Hospital
  • Principal Investigator: Michael Böhm, MD, Universitätskliniken des Saarlandes
  • Principal Investigator: Kazuomi Kario, MD, Jichi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2015

Primary Completion (Actual)

August 18, 2022

Study Completion (Actual)

August 14, 2025

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimated)

May 12, 2015

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

October 30, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPYRAL HTN-ON MED

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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