SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

September 9, 2026 updated by: Medtronic Vascular

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1899

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital (Dobney Hypertension Centre)
  • Belgium
      • Bruges, Belgium, 8000
        • AZ Sint Jan Brugge-Oostende av
      • Genk, Belgium, 3600
        • Ziekenhuis Oost Limburg - Campus Sint-Jan
      • Ghent, Belgium, 9000
        • University Hospital Ghent
      • Liège, Belgium, 4000
        • CHC MontLégia
    • Oost - Vlaanderen
      • Aalst, Oost - Vlaanderen, Belgium, 9300
        • Algemeen Stedelijk Ziekenhuis - R&D Hartziekten
  • France
      • Bordeaux, France, 33 000
        • Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux
      • Paris, France, 75013
        • Hôpital Pitie Salpétrière
  • Germany
      • Erlangen, Germany, 91054
        • Uniklinik Erlangen
      • Giessen, Germany, 35390
        • Justus-Liebig-Universität Gießen
      • Homburg, Germany
        • Universitatsklinikum des Saarlandes
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig
      • Lübeck, Germany, 23560
        • Sana Kliniken Lübeck GmbH
  • Greece
      • Athens, Greece, 11527
        • Hippokration General Hospital of Athens
  • Ireland
    • Dublin
      • Dublin, Dublin, Ireland, D07 R2WY
        • Mater Misericordiae University Hospital
  • Monaco
      • Monaco, Monaco, 98000
        • Centre Hospitalier Princesse Grace
  • Netherlands
      • Heerlen, Netherlands, 6419 PC
        • Zuyderland Medisch Centrum Heerlen
      • Rotterdam, Netherlands
        • Erasmus Universtiy Medical Center
  • Sweden
      • Stockholm, Sweden, 18288
        • Danderyd Sjukhus
  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham (UAB) Hospital
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Banner Heart Hospital
      • Phoenix, Arizona, United States, 85016
        • Abrazo Arizona Heart Hospital/Biltmore Cardiology
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cardiology
    • California
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
      • Lakewood, Colorado, United States, 80228
        • Colorado Heart and Vascular PC
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Clearwater, Florida, United States, 33756
        • Clearwater Cardiovascular Consultants
      • Clearwater, Florida, United States, 33756
        • BayCare Health System
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center
      • Miami, Florida, United States, 33136
        • University of Miami Hosptial
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Orlando, Florida, United States, 32806
        • Orlando Health Heart & Vascular Institute
      • Safety Harbor, Florida, United States, 34695
        • BayCare Medical Group
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Healthcare, Inc
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
      • Marietta, Georgia, United States, 30060
        • Wellstar Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine
      • Maywood, Illinois, United States, 60153-3328
        • Loyola University Medical Center
      • Palos Park, Illinois, United States, 60464
        • Heart Care Centers of Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • St. Vincents Hospital
    • Iowa
      • West Des Moines, Iowa, United States, 50266-8209
        • Mercy Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital
      • Towson, Maryland, United States, 21204
        • Saint Joseph Medical Center (Towson MD)
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48236
        • Henry Ford Saint John Hospital
      • Grand Rapids, Michigan, United States, 49503-2560
        • Spectrum Health Hospitals
      • Pontiac, Michigan, United States, 48341
        • Saint Joseph Mercy Oakland
      • Southfield, Michigan, United States, 48075
        • Henry Ford Providence Southfield Hospital
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Metropolitan Heart and Vascular Institute (MHVI)
      • Saint Cloud, Minnesota, United States, 56303-1900
        • CentraCare Heart & Vascular Center
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • University of Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Virtua Medical Group
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital
    • New York
      • Liverpool, New York, United States, 13088
        • SJH Cardiology Associates
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10021-9800
        • Weill Cornell Medical Center
      • Roslyn, New York, United States, 11576-1348
        • Saint Francis Hospital
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Sanford Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • UPMC Harrisburg Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
    • Texas
      • Dallas, Texas, United States, 75226-1316
        • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
      • Edinburg, Texas, United States, 78539
        • DHR Health Institute for Research and Development
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • Plano, Texas, United States, 75093
        • Baylor Scott & White The Heart Hospital Baylor Plano
      • San Antonio, Texas, United States, 78229
        • Methodist Hospital
      • Tyler, Texas, United States, 75701
        • The University of Texas at Tyler
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • UVA Medical Center
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Medical Center Everett
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
  2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
  3. Individual has an average systolic baseline home blood pressure ≥135 mmHg

Exclusion Criteria:

  1. Individual lacks appropriate renal artery anatomy
  2. Individual has undergone prior renal denervation
  3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
  4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
  5. Individual has an estimated glomerular filtration rate (eGFR) of <45
  6. Individual has one or more episode(s) of orthostatic hypotension
  7. Individual is pregnant, nursing or planning to become pregnant
  8. Individual has primary pulmonary hypertension
  9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Main Cohort: Renal Denervation
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.
Other Names:
  • Renal Denervation
  • Renal Angiography

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.
Time Frame: 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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Office Systolic Blood Pressure change
Time Frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
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
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
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
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
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
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
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
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
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
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
From baseline to 3, 6, 12, 24, and 36 months post-procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Vascular

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Kandzari, MD, Piedmont Heart Institute
  • Principal Investigator: Felix Mahfoud, MD, Saarland University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDT20044RDN004
  • SPYRAL SWFYT (NCT07115953) (Other Identifier: ClinicalTrials.gov)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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