HypertensionNCT05198674
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
A study testing Renal Denervation (Symplicity Spyral™) in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 97 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- What is being tested?
- Renal Denervation (Symplicity Spyral™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,899 participants
- Where
- 97 sitesin 11 countries
- Study dates
- 20 Oct 2021to 30 Nov 2029
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individual lacks appropriate renal artery anatomy
- Individual has undergone prior renal denervation
- Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- Individual has an estimated glomerular filtration rate (eGFR) of <45
- Individual has one or more episode(s) of orthostatic hypotension
Show all 9Show fewer
- Individual is pregnant, nursing or planning to become pregnant
- Individual has primary pulmonary hypertension
- Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
Trial locations and contacts
97 sites in 11 countries.
97 sites in 11 countries
United States76 sites
AnMed Health Medical Center
Anderson, South Carolina, 29621
University of Michigan
Ann Arbor, Michigan, 48109
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Piedmont Heart Institute
Atlanta, Georgia, 30309
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35233
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Vermont Medical Center
Burlington, Vermont, 05401
University of North Carolina
Chapel Hill, North Carolina, 27599
UVA Medical Center
Charlottesville, Virginia, 22908
University of Chicago Medicine
Chicago, Illinois, 60637
The Lindner Center
Cincinnati, Ohio, 45219
BayCare Health System
Clearwater, Florida, 33756
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Riverside Methodist Hospital
Columbus, Ohio, 43214
Metropolitan Heart and Vascular Institute (MHVI)
Coon Rapids, Minnesota, 55433
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75226-1316
Henry Ford Hospital
Detroit, Michigan, 48202
Henry Ford Saint John Hospital
Detroit, Michigan, 48236
Duke University Medical Center
Durham, North Carolina, 27710
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
Providence Regional Medical Center Everett
Everett, Washington, 98201
Sanford Medical Center
Fargo, North Dakota, 58102
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503-2560
UPMC Harrisburg Hospital
Harrisburg, Pennsylvania, 17101
Hartford Hospital
Hartford, Connecticut, 06102
Houston Methodist
Houston, Texas, 77030
St. Vincents Hospital
Indianapolis, Indiana, 46290
Baptist Medical Center
Jacksonville, Florida, 32207
Scripps Memorial Hospital
La Jolla, California, 92037
Colorado Heart and Vascular PC
Lakewood, Colorado, 80228
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756
Arkansas Cardiology
Little Rock, Arkansas, 72205
SJH Cardiology Associates
Liverpool, New York, 13088
North Shore University Hospital
Manhasset, New York, 11030
Wellstar Research Institute
Marietta, Georgia, 30060
Virtua Medical Group
Marlton, New Jersey, 08053
Loyola University Medical Center
Maywood, Illinois, 60153-3328
Banner Heart Hospital
Mesa, Arizona, 85206
University of Miami Hosptial
Miami, Florida, 33136
Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC)
Milwaukee, Wisconsin, 53215
West Virginia University
Morgantown, West Virginia, 26506
Morristown Medical Center
Morristown, New Jersey, 07960
Intermountain Medical Center
Murray, Utah, 84107
Centennial Medical Center
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Weill Cornell Medical Center
New York, New York, 10021-9800
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
University of Nebraska Medical Center
Omaha, Nebraska, 68105
AdventHealth Orlando
Orlando, Florida, 32803
Orlando Health Heart & Vascular Institute
Orlando, Florida, 32806
Heart Care Centers of Illinois
Palos Park, Illinois, 60464
The Valley Hospital
Paramus, New Jersey, 07652
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Abrazo Arizona Heart Hospital/Biltmore Cardiology
Phoenix, Arizona, 85016
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Baylor Scott & White The Heart Hospital Baylor Plano
Plano, Texas, 75093
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341
The Miriam Hospital
Providence, Rhode Island, 02906
Saint Francis Hospital
Roslyn, New York, 11576-1348
BayCare Medical Group
Safety Harbor, Florida, 34695
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303-1900
Methodist Hospital
San Antonio, Texas, 78229
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Henry Ford Providence Southfield Hospital
Southfield, Michigan, 48075
Stanford Hospital and Clinics
Stanford, California, 94305
Tallahassee Memorial Healthcare, Inc
Tallahassee, Florida, 32308
Montefiore Medical Center
The Bronx, New York, 10467
Saint Joseph Medical Center (Towson MD)
Towson, Maryland, 21204
North Mississippi Medical Center
Tupelo, Mississippi, 38801
The University of Texas at Tyler
Tyler, Texas, 75701
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Mercy Medical Center
West Des Moines, Iowa, 50266-8209
Belgium5 sites
Algemeen Stedelijk Ziekenhuis - R&D Hartziekten
Aalst, Oost - Vlaanderen, 9300
AZ Sint Jan Brugge-Oostende av
Bruges, 8000
Ziekenhuis Oost Limburg - Campus Sint-Jan
Genk, 3600
University Hospital Ghent
Ghent, 9000
Chc Montlegia
Liège, 4000
Germany5 sites
Uniklinik Erlangen
Erlangen, 91054
Justus-Liebig-Universität Gießen
Giessen, 35390
Universitatsklinikum des Saarlandes
Homburg
Herzzentrum Leipzig
Leipzig, 04289
Sana Kliniken Lübeck GmbH
Lübeck, 23560
Australia2 sites
The Alfred Hospital
Melbourne, Victoria, 3004
Royal Perth Hospital (Dobney Hypertension Centre)
Perth, Western Australia, 6000
France2 sites
Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33 000
Hôpital Pitié Salpêtrière
Paris, 75013
Netherlands2 sites
Zuyderland Medisch Centrum Heerlen
Heerlen, 6419 PC
Erasmus Universtiy Medical Center
Rotterdam
Ireland1 site
Mater Misericordiae University Hospital
Dublin, Dublin, D07 R2WY
United Kingdom1 site
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)
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.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus
- Being tested
- Renal Denervation (Symplicity Spyral™)
- Medical subject headings
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Denervation (Symplicity Spyral™)Device
Also called Renal Angiography, Renal Denervation
Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort: Renal Denervation | Experimental | Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Receives: Device: Renal Denervation (Symplicity Spyral™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (11)
Office Systolic Blood Pressure change
Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Home Blood Pressure change (Main Cohort Only)
Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Change in blood pressure as measured by 24-hour ABPM
Measured: 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
Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Time subject's blood pressure is controlled
Measured: Procedure to 36 months post-procedure
Change in number of anti-hypertensive medications taken from baseline
Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Change from baseline in EQ-5D quality of life score
Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Change from baseline in hypertension health status score
Measured: 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
Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Evaluation of slope of eGFR
Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Incidence of events, including major adverse events
Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start20 Oct 2021
- Primary completion5 Mar 2026
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,899 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Kandzari, MD, Principal investigator, Piedmont Heart InstituteFelix Mahfoud, MD, Principal investigator, Saarland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198674
- Sponsor's protocol ID
- MDT20044RDN004
- Other IDs
- SPYRAL SWFYT (NCT07115953)
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Abid S, Mehta S, Munazzah F, Yager N, Baloch S, Hongalgi K. Renal Denervation: A New Era in the Management of Resistant Hypertension. Kidney360. 2025 Nov 1;6(11):2010-2016. doi: 10.34067/KID.0000000961. Epub 2025 Aug 13.
PubMed 40802676