Global Paradise System US Post Approval Study (NCT06297291)
The Global Paradiseยฎ System US Post Approval Study (US GPS)
๐ฉบ Plain-English Summary (8th-Grade Level)
The objective of the Global Paradiseยฎ 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.
Who can join: Review the eligibility criteria below.
Location: Tibor Rubin VA Medical Center โ Long Beach, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (43 Sites)
Showing the first 25 of 43 sites.
- Tibor Rubin VA Medical Center โ Long Beach, California
- Cedars-Sinai Medical Center โ Los Angeles, California
- Sutter Institute for Medical Research โ Sacramento, California
- UC Davis Medical Center โ Sacramento, California
- Pacific Heart Institute โ Santa Monica, California
- Rocky Mountain Regional VAMC โ Aurora, Colorado
- Medical Center of the Rockies โ Loveland, Colorado
- Bridgeport Hosptial โ Bridgeport, Connecticut
- The Cardiac & Vascular Institute โ Gainesville, Florida
- University of Miami Health System โ Miami, Florida
- Ascension Sacred Heart โ Pensacola, Florida
- Tampa Cardiovascular Interventions and Research โ Tampa, Florida
- Wellstar Kennestone Hospital โ Marietta, Georgia
- Southern Illinois University, Memorial Medical Center โ Springfield, Illinois
- Ascension via Christi St. Francis โ Wichita, Kansas
- Touro Infirmary โ New Orleans, Louisiana
- Massachusetts General Hospital โ Boston, Massachusetts
- The Brigham and Women's Hospital โ Boston, Massachusetts
- Henry Ford Health โ Detroit, Michigan
- Henry Ford St. John Hospital โ Detroit, Michigan
- Metropolitan Heart & Vascular Institute โ Coon Rapids, Minnesota
- Saint Luke's Mid America Heart Institute โ Kansas City, Missouri
- Virtua Health โ Marlton, New Jersey
- Albany Medical Center โ Albany, New York
- NewYork-Presbyterian Brooklyn Methodist Hospital โ Brooklyn, New York
๐ Contact the Study Coordinator
Phone: (650) 912-9032
Email: hreeve-stoffer@recormedical.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.