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Global Paradise System US Post Approval Study
Sponsor: ReCor Medical, Inc.
Summary
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.
Official title: The Global Paradise® System US Post Approval Study (US GPS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2024-06-28
Completion Date
2031-07
Last Updated
2026-01-14
Healthy Volunteers
No
Interventions
Paradise Ultrasound Renal Denervation Treatment
The Paradise Ultrasound Renal Denervation System (Paradise Ultrasound RDN) is an FDA-approved catheter-based system to treat hypertension by ablating the nerves around the renal arteries, disrupting the overactive sympathetic nerves that can cause high blood pressure. The Paradise procedure uses ultrasound energy to calm the nerves near the kidneys to help lower blood pressure. Treatment is usually done in an outpatient setting and typically takes about an hour to perform. As a part of the treatment, a small flexible tube (catheter) is guided into the blood vessels near the kidneys and 7 seconds of ultrasound energy is applied 2-3 times. Both sides are treated and then the catheter is removed, leaving nothing behind. After the procedure, some people go home the same day or some stay overnight.
Locations (34)
Sutter Institute for Medical Research
Sacramento, California, United States
UC Davis Medical Center
Sacramento, California, United States
Rocky Mountain Regional VAMC
Aurora, Colorado, United States
Bridgeport Hosptial
Bridgeport, Connecticut, United States
The Cardiac & Vascular Institute
Gainesville, Florida, United States
University of Miami Health System
Miami, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Tampa Cardiovascular Interventions and Research
Tampa, Florida, United States
Southern Illinois University, Memorial Medical Center
Springfield, Illinois, United States
Ascension via Christi St. Francis
Wichita, Kansas, United States
Touro Infirmary
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
The Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Health
Detroit, Michigan, United States
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, United States
Virtua Health
Marlton, New Jersey, United States
Albany Medical Center
Albany, New York, United States
University at Buffalo
Buffalo, New York, United States
NYU Langone Health - Bellevue Hosptial
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States
Durham VA Health System
Durham, North Carolina, United States
UPMC Harrisburg
Harrisburg, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Ascension Saint Thomas
Nashville, Tennessee, United States
Ascension Seton
Austin, Texas, United States
Dallas VAMC
Dallas, Texas, United States
TCR Institute
Kingwood, Texas, United States
St. Mark's Hospital
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Fairfax, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States