SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
Launched by MEDTRONIC VASCULAR · Jan 6, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The SPYRAL AFFIRM study is looking at a new treatment for people with high blood pressure (hypertension) who have not been able to control it with medication alone. The trial will test a device called the Symplicity Spyral system, which is designed to help lower blood pressure by targeting the nerves around the kidneys. This study aims to find out how safe and effective this treatment is over the long term.
To participate, you need to have high blood pressure, with specific measurements indicating that it’s not well controlled. For example, your systolic blood pressure (the top number) needs to be at least 140 mmHg. However, there are some conditions that would exclude you from joining, such as having certain kidney issues or other serious health problems. If you join the study, you will receive the treatment and be monitored to see how your blood pressure responds over time. This trial is currently recruiting participants aged 65 to 74, and both men and women can take part.
Gender
ALL
Eligibility criteria
- 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%
About Medtronic Vascular
Medtronic Vascular is a leading global medical technology company dedicated to transforming patient care through innovative vascular solutions. With a strong focus on advancing minimally invasive therapies, Medtronic Vascular develops cutting-edge devices and therapies aimed at treating a wide range of vascular conditions, including peripheral artery disease, coronary artery disease, and structural heart disorders. Committed to improving outcomes and enhancing quality of life for patients, the company actively engages in clinical trials to evaluate the safety and efficacy of its products. Medtronic Vascular leverages its expertise and extensive research to deliver state-of-the-art technologies that empower healthcare professionals and improve patient experiences worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Ann Arbor, Michigan, United States
Baltimore, Maryland, United States
Durham, North Carolina, United States
San Francisco, California, United States
Bronx, New York, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Manhasset, New York, United States
Las Vegas, Nevada, United States
Pittsburgh, Pennsylvania, United States
Orlando, Florida, United States
Chapel Hill, North Carolina, United States
Hartford, Connecticut, United States
Columbus, Ohio, United States
Nashville, Tennessee, United States
Morgantown, West Virginia, United States
Washington, District Of Columbia, United States
Morristown, New Jersey, United States
Tupelo, Mississippi, United States
Cincinnati, Ohio, United States
Pontiac, Michigan, United States
Melbourne, Victoria, Australia
Murray, Utah, United States
Burlington, Vermont, United States
Oklahoma City, Oklahoma, United States
Stanford, California, United States
Jacksonville, Florida, United States
Nashville, Tennessee, United States
La Jolla, California, United States
Leipzig, , Germany
San Antonio, Texas, United States
Paramus, New Jersey, United States
Paris, , France
Neptune, New Jersey, United States
Atlanta, Georgia, United States
Liverpool, New York, United States
Atlanta, Georgia, United States
Omaha, Nebraska, United States
Erlangen, , Germany
Oxford, Oxfordshire, United Kingdom
Lebanon, New Hampshire, United States
Anderson, South Carolina, United States
Gent, , Belgium
Cleveland, Ohio, United States
Maywood, Illinois, United States
Monaco, , Monaco
Little Rock, Arkansas, United States
Mesa, Arizona, United States
Chicago, Illinois, United States
Everett, Washington, United States
Heerlen, , Netherlands
Charlottesville, Virginia, United States
Aurora, Colorado, United States
Marietta, Georgia, United States
Boston, Massachusetts, United States
Dallas, Texas, United States
Southfield, Michigan, United States
Clearwater, Florida, United States
Fargo, North Dakota, United States
Houston, Texas, United States
Scottsdale, Arizona, United States
Brugge, , Belgium
Homburg, , Germany
Athens, , Greece
Dublin, , Ireland
Lübeck, , Germany
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Birmingham, Alabama, United States
Genk, , Belgium
Liège, , Belgium
Miami, Florida, United States
Edinburg, Texas, United States
Stockholm, , Sweden
Plano, Texas, United States
Palos Park, Illinois, United States
Harrisburg, Pennsylvania, United States
Saint Cloud, Minnesota, United States
Tyler, Texas, United States
Coon Rapids, Minnesota, United States
West Des Moines, Iowa, United States
New York, New York, United States
Aalst, Oost Vlaanderen, Belgium
Rotterdam, , Netherlands
Indianapolis, Indiana, United States
Orlando, Florida, United States
Tallahassee, Florida, United States
Bordeaux, , France
Towson, Maryland, United States
Phoenix, Arizona, United States
Milwaukee, Wisconsin, United States
Gießen, , Germany
Clearwater, Florida, United States
Safety Harbor, Florida, United States
Providence, Rhode Island, United States
Perth, Western Australia, Australia
Cleveland, Ohio, United States
Roslyn, New York, United States
Lakewood, Colorado, United States
Marlton, New Jersey, United States
Towson, Maryland, United States
Detroit, Michigan, United States
Southfield, Michigan, United States
Perth, Western Australia, Australia
Patients applied
Trial Officials
David Kandzari, MD
Principal Investigator
Piedmont Heart Institute
Felix Mahfoud, MD
Principal Investigator
Saarland University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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