SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
Public ClinicalTrials.gov record NCT05198674. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05198674
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,899 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 20, 2021 (Actual)
- Primary completion
- Mar 5, 2026 (Actual)
- Completion
- Nov 30, 2029 (Estimated)
- Last update posted
- Oct 16, 2026
2021 – 2029
United States locations
- U.S. sites
- 76
- U.S. states
- 36
- U.S. cities
- 70
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) Hospital | Birmingham | Alabama | 35233 | — |
| Banner Heart Hospital | Mesa | Arizona | 85206 | — |
| Abrazo Arizona Heart Hospital/Biltmore Cardiology | Phoenix | Arizona | 85016 | — |
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | — |
| Arkansas Cardiology | Little Rock | Arkansas | 72205 | — |
| Scripps Memorial Hospital | La Jolla | California | 92037 | — |
| Stanford Hospital and Clinics | Stanford | California | 94305 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Colorado Heart and Vascular PC | Lakewood | Colorado | 80228 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| BayCare Health System | Clearwater | Florida | 33756 | — |
| Clearwater Cardiovascular Consultants | Clearwater | Florida | 33756 | — |
| Baptist Medical Center | Jacksonville | Florida | 32207 | — |
| University of Miami Hosptial | Miami | Florida | 33136 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Orlando Health Heart & Vascular Institute | Orlando | Florida | 32806 | — |
| BayCare Medical Group | Safety Harbor | Florida | 34695 | — |
| Tallahassee Memorial Healthcare, Inc | Tallahassee | Florida | 32308 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | — |
| Wellstar Research Institute | Marietta | Georgia | 30060 | — |
| University of Chicago Medicine | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153-3328 | — |
| Heart Care Centers of Illinois | Palos Park | Illinois | 60464 | — |
| St. Vincents Hospital | Indianapolis | Indiana | 46290 | — |
| Mercy Medical Center | West Des Moines | Iowa | 50266-8209 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Saint Joseph Medical Center (Towson MD) | Towson | Maryland | 21204 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Henry Ford Saint John Hospital | Detroit | Michigan | 48236 | — |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503-2560 | — |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341 | — |
| Henry Ford Providence Southfield Hospital | Southfield | Michigan | 48075 | — |
| Metropolitan Heart and Vascular Institute (MHVI) | Coon Rapids | Minnesota | 55433 | — |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | 56303-1900 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | — |
| Dartmouth-Hitchcock | Lebanon | New Hampshire | 03756 | — |
| Virtua Medical Group | Marlton | New Jersey | 08053 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| The Valley Hospital | Paramus | New Jersey | 07652 | — |
| SJH Cardiology Associates | Liverpool | New York | 13088 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Weill Cornell Medical Center | New York | New York | 10021-9800 | — |
| Saint Francis Hospital | Roslyn | New York | 11576-1348 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Sanford Medical Center | Fargo | North Dakota | 58102 | — |
| The Lindner Center | Cincinnati | Ohio | 45219 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | — |
| UPMC Harrisburg Hospital | Harrisburg | Pennsylvania | 17101 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| The Miriam Hospital | Providence | Rhode Island | 02906 | — |
| AnMed Health Medical Center | Anderson | South Carolina | 29621 | — |
| Centennial Medical Center | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Dallas | Texas | 75226-1316 | — |
| DHR Health Institute for Research and Development | Edinburg | Texas | 78539 | — |
| Houston Methodist | Houston | Texas | 77030 | — |
| Baylor Scott & White The Heart Hospital Baylor Plano | Plano | Texas | 75093 | — |
| Methodist Hospital | San Antonio | Texas | 78229 | — |
| The University of Texas at Tyler | Tyler | Texas | 75701 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| UVA Medical Center | Charlottesville | Virginia | 22908 | — |
| Providence Regional Medical Center Everett | Everett | Washington | 98201 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC) | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05198674, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05198674 live on ClinicalTrials.gov.