๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-10

Global Paradise System US Post Approval Study (NCT06297291)

The Global Paradiseยฎ System US Post Approval Study (US GPS)

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: ReCor Medical, Inc.

๐Ÿฉบ 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

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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

๐Ÿ“ž 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.

๐Ÿ’ฐ 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.

Explore by condition: All Hypertension clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—