Actively Recruiting
Global Paradise System US Post Approval Study
Led by ReCor Medical, Inc. · Updated on 2026-05-07
1000
Participants Needed
39
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.
CONDITIONS
Official Title
Global Paradise System US Post Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated study informed consent
- Documented history of hypertension
- Documented history of prior or current antihypertensive medication(s)
- Mean seated office systolic blood pressure at screening greater than or equal to 140 mmHg
- Mean pre-procedure home systolic blood pressure greater than or equal to 135 mmHg
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/m2 or higher
You will not qualify if you...
- Patient lacks appropriate renal anatomy for treatment with the Paradise Catheter
- Patient under 18 years old at the time of consent
- Patient is pregnant
- Patients with transplanted kidney
- Presence of abnormal kidney or secreting adrenal tumors
- Renal arteries with diameter less than 3mm or greater than 8mm
- Renal artery with fibromuscular dysplasia (FMD)
- Stented renal artery
- Renal artery aneurysm
- Renal artery diameter stenosis greater than 30%
- Iliac or femoral artery stenosis that prevents insertion of the Paradise Catheter
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
Actively Recruiting
2
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
3
Pacific Heart Institute
Santa Monica, California, United States, 90404
Actively Recruiting
4
Rocky Mountain Regional VAMC
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Bridgeport Hosptial
Bridgeport, Connecticut, United States, 06610
Actively Recruiting
6
The Cardiac & Vascular Institute
Gainesville, Florida, United States, 32605
Actively Recruiting
7
University of Miami Health System
Miami, Florida, United States, 33136
Actively Recruiting
8
Ascension Sacred Heart
Pensacola, Florida, United States, 32504
Actively Recruiting
9
Tampa Cardiovascular Interventions and Research
Tampa, Florida, United States, 33614
Actively Recruiting
10
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Actively Recruiting
11
Southern Illinois University, Memorial Medical Center
Springfield, Illinois, United States, 62702
Actively Recruiting
12
Ascension via Christi St. Francis
Wichita, Kansas, United States, 67214
Actively Recruiting
13
Touro Infirmary
New Orleans, Louisiana, United States, 70112
Actively Recruiting
14
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
15
The Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
16
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
17
Metropolitan Heart & Vascular Institute
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
18
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, United States, 64111
Actively Recruiting
19
Virtua Health
Marlton, New Jersey, United States, 08053
Actively Recruiting
20
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
21
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Actively Recruiting
22
University at Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
23
NYU Langone Health - Bellevue Hosptial
New York, New York, United States, 10016
Actively Recruiting
24
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
25
Stony Brook Medicine
Stony Brook, New York, United States, 11794
Actively Recruiting
26
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
27
Durham VA Health System
Durham, North Carolina, United States, 27705
Actively Recruiting
28
UPMC Harrisburg
Harrisburg, Pennsylvania, United States, 17110
Actively Recruiting
29
Penn Medicine
Phildelphia, Pennsylvania, United States, 19104
Actively Recruiting
30
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
31
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
32
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
33
Ascension Saint Thomas
Nashville, Tennessee, United States, 37205
Actively Recruiting
34
Ascension Seton
Austin, Texas, United States, 78705
Actively Recruiting
35
Dallas VAMC
Dallas, Texas, United States, 75216
Actively Recruiting
36
TCR Institute
Kingwood, Texas, United States, 77339
Actively Recruiting
37
St. Mark's Hospital
Salt Lake City, Utah, United States, 84124
Actively Recruiting
38
Inova Fairfax Hospital
Fairfax, Virginia, United States, 22042
Actively Recruiting
39
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
Research Team
H
Helen Reeve-Stoffer, PhD
CONTACT
L
Liz Sheehan
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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