Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SPYRAL SWFYT (NCT07115953) | Other Identifier | ClinicalTrials.gov |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Cohort: Renal Denervation | Experimental | Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation (Symplicity Spyral™) | Device | Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Office Systolic Blood Pressure change | From baseline to 3, 6, 12, 24, and 36 months post-procedure | |
| Home Blood Pressure change (Main Cohort Only) | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Kandzari, MD | Piedmont Heart Institute | Principal Investigator |
| Felix Mahfoud, MD | Saarland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) Hospital | Birmingham | Alabama | 35233 | United States | ||
| Banner Heart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40802676 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Change in blood pressure as measured by 24-hour ABPM | 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 | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Time subject's blood pressure is controlled | Procedure to 36 months post-procedure |
| Change in number of anti-hypertensive medications taken from baseline | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Change from baseline in EQ-5D quality of life score | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Change from baseline in hypertension health status score | 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 | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Evaluation of slope of eGFR | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Incidence of events, including major adverse events | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Mesa |
| Arizona |
| 85206 |
| United States |
| Abrazo Arizona Heart Hospital/Biltmore Cardiology | Phoenix | Arizona | 85016 | United States |
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States |
| Arkansas Cardiology | Little Rock | Arkansas | 72205 | United States |
| Scripps Memorial Hospital | La Jolla | California | 92037 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Stanford Hospital and Clinics | Stanford | California | 94305 | United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| Colorado Heart and Vascular PC | Lakewood | Colorado | 80228 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| BayCare Health System | Clearwater | Florida | 33756 | United States |
| Clearwater Cardiovascular Consultants | Clearwater | Florida | 33756 | United States |
| Baptist Medical Center | Jacksonville | Florida | 32207 | United States |
| University of Miami Hosptial | Miami | Florida | 33136 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Orlando Health Heart & Vascular Institute | Orlando | Florida | 32806 | United States |
| BayCare Medical Group | Safety Harbor | Florida | 34695 | United States |
| Tallahassee Memorial Healthcare, Inc | Tallahassee | Florida | 32308 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Wellstar Research Institute | Marietta | Georgia | 30060 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153-3328 | United States |
| Heart Care Centers of Illinois | Palos Park | Illinois | 60464 | United States |
| St. Vincents Hospital | Indianapolis | Indiana | 46290 | United States |
| Mercy Medical Center | West Des Moines | Iowa | 50266-8209 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Saint Joseph Medical Center (Towson MD) | Towson | Maryland | 21204 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Henry Ford Saint John Hospital | Detroit | Michigan | 48236 | United States |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503-2560 | United States |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341 | United States |
| Henry Ford Providence Southfield Hospital | Southfield | Michigan | 48075 | United States |
| Metropolitan Heart and Vascular Institute (MHVI) | Coon Rapids | Minnesota | 55433 | United States |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | 56303-1900 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Dartmouth-Hitchcock | Lebanon | New Hampshire | 03756 | United States |
| Virtua Medical Group | Marlton | New Jersey | 08053 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
| SJH Cardiology Associates | Liverpool | New York | 13088 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Weill Cornell Medical Center | New York | New York | 10021-9800 | United States |
| Saint Francis Hospital | Roslyn | New York | 11576-1348 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Sanford Medical Center | Fargo | North Dakota | 58102 | United States |
| The Lindner Center | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Cl inic | Cleveland | Ohio | 44195 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | United States |
| UPMC Harrisburg Hospital | Harrisburg | Pennsylvania | 17101 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Rhode Island Hospital and Health Services | Providence | Rhode Island | 02906 | United States |
| AnMed Health Medical Center | Anderson | South Carolina | 29621 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Dallas | Texas | 75226-1316 | United States |
| DHR Health Institute for Research and Development | Edinburg | Texas | 78539 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Baylor Scott & White The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Methodist Hospital | San Antonio | Texas | 78229 | United States |
| The University of Texas at Tyler | Tyler | Texas | 75701 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| UVA Medical Center | Charlottesville | Virginia | 22908 | United States |
| Providence Regional Medical Center Everett | Everett | Washington | 98201 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC) | Milwaukee | Wisconsin | 53215 | United States |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Royal Perth Hospital (Dobney Hypertension Centre) | Perth | Western Australia | 6000 | Australia |
| Algemeen Stedelijk Ziekenhuis - R&D Hartziekten | Aalst | Oost - Vlaanderen | 9300 | Belgium |
| AZ Sint Jan Brugge-Oostende av | Bruges | 8000 | Belgium |
| Ziekenhuis Oost Limburg - Campus Sint-Jan | Genk | 3600 | Belgium |
| University Hospital Ghent | Ghent | 9000 | Belgium |
| Chc Montlegia | Liège | 4000 | Belgium |
| Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux | Bordeaux | 33 000 | France |
| Hôpital Pitié Salpêtrière | Paris | 75013 | France |
| Uniklinik Erlangen | Erlangen | 91054 | Germany |
| Justus-Liebig-Universität Gießen | Giessen | 35390 | Germany |
| Universitatsklinikum des Saarlandes | Homburg | Germany |
| Herzzentrum Leipzig | Leipzig | 04289 | Germany |
| Sana Kliniken Lübeck GmbH | Lübeck | 23560 | Germany |
| Hippokration General Hospital of Athens | Athens | 11527 | Greece |
| Mater Misericordiae University Hospital | Dublin | D07 R2WY | Ireland |
| Centre Hospitalier Princesse Grace | Monaco | 98000 | Monaco |
| Zuyderland Medisch Centrum Heerlen | Heerlen | 6419 PC | Netherlands |
| Erasmus Universtiy Medical Center | Rotterdam | Netherlands |
| Danderyd Sjukhus | Stockholm | 18288 | Sweden |
| John Radcliffe Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided