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
RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation | Device | Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | From baseline to 60 months | |
| Change in average daytime ambulatory systolic BP | From baseline to 2 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average 24-hr/night-time ambulatory systolic BP | From baseline to 2 months post procedure | |
| Change in average daytime/24-hr/night-time ambulatory systolic BP | From Baseline to Months 6 and 12 post procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Naomi Fisher, MD | Brigham and Women's Hospital/Harvard Medical School | Principal Investigator |
| Ajay Kirtane, MD, SM | Columbia University Medical Center/NYPH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute of San Diego | Chula Vista | California | 91911 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34010611 | Background | Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmieder RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. doi: 10.1016/S0140-6736(21)00788-1. Epub 2021 May 16. |
| Label | URL |
|---|---|
| ReCor Medical company website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in average office systolic/diastolic BP | From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure |
| Change in average home systolic/diastolic BP | From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure |
| Change in average 24-hr/night-time ambulatory diastolic BP | From baseline to Months 2, 6, and 12 post procedure |
| Los Angeles |
| California |
| 90048 |
| United States |
| Sutter Health | Sacramento | California | 95816 | United States |
| Pacific Heart Institute | Santa Monica | California | 90404 | United States |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States |
| The Cardiac and Vascular Institute | Gainesville | Florida | 32604 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| Orlando Health | Orlando | Florida | 32806 | United States |
| Emory | Atlanta | Georgia | 30308 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62701 | United States |
| SIU Medicine | Springfield | Illinois | 62794-9664 | United States |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | United States |
| UnityPoint Health-Des Moines | Des Moines | Iowa | 50309 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Lifebridge Health | Baltimore | Maryland | 21215 | United States |
| Tidal Health | Salisbury | Maryland | 21804 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| The Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States |
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Cardiovascular Associates of the Delaware Valley | Haddon Heights | New Jersey | 08035 | United States |
| NJ Heart & Vascular | Princeton | New Jersey | 08540 | United States |
| NYU Langone Hospital - Long Island | Mineola | New York | 001501 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Columbia University Medical Center/NYPH | New York | New York | 10032 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794-8167 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599-7075 | United States |
| Cone Health | Greensboro | North Carolina | 27401 | United States |
| St. Francis Hospital | Tulsa | Oklahoma | 74136 | United States |
| Penn Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Heart and Vascular Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| The University of Texas Health Sciences Center at Houston | Houston | Texas | 77030 | United States |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | United States |
| University of Texas Health Sciences Center, San Antonio | San Antonio | Texas | 78229 | United States |
| Baylor Scott & White Research Institute | Temple | Texas | 76508 | United States |
| Swedish Health Services | Seattle | Washington | 98122 | United States |
| Study eligibility questionnaire; study summary and information | View source |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| C563514 | Hypertension Resistant to Conventional Therapy |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000075222 | Essential Hypertension |
Not provided
Not provided
Not provided