🏛️ Verified NIH Record • Updated 2026-07-31

THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension (NCT06559891)

A Pivotal, Prospective, Multicenter, 2:1 Randomized, Double Blind, Controlled, Study Comparing the THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension (The THRIVE Study)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: SoniVie Inc.

🩺 Plain-English Summary (8th-Grade Level)

The primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in: 1. subjects with uncontrolled hypertension (HTN) receiving 0 - 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDN/Sham procedure and during 2 months after procedure. 2. subjects with controlled hypertension receiving 1 - 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after the procedure

Who can join: Review the eligibility criteria below.

Location: Cardiology, PC — Birmingham, Alabama

Age range: 22 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (50 Sites)

Showing the first 25 of 50 sites.

  • Cardiology, PC — Birmingham, Alabama
  • HonorHealth — Scottsdale, Arizona
  • St. Bernard's Medical Center — Jonesboro, Arkansas
  • Arkansas Heart Hospital — Little Rock, Arkansas
  • Cedar-Sinai Medical Center — Los Angeles, California
  • Stanford University — Palo Alto, California
  • Connecticut Clinical Research, LLC (Bridgeport) — Bridgeport, Connecticut
  • Ascension- Sacred Heart — Pensecola, Florida
  • University of South Florida — Tampa, Florida
  • Ascension Alexian Brothers — Elk Grove Village, Illinois
  • St. John's Prairie Heart — Springfield, Illinois
  • Southern Illinois University, School of Medicine — Springfield, Illinois
  • Cardiovascular Institute of the South — Houma, Louisiana
  • Ochsner Medical Center — New Orleans, Louisiana
  • Henry Ford Hospital — Detroit, Michigan
  • Henry Ford Providence Hospital — Southfield, Michigan
  • Gulfport Memorial Hospital — Gulfport, Mississippi
  • Jackson Heart Clinic — Jackson, Mississippi
  • St Lukes Hospital — Kansas City, Missouri
  • Renown Regional Medical Center — Reno, Nevada
  • Virtua Health — Camden, New Jersey
  • Jersey Shore University Medical Center — Neptune City, New Jersey
  • St. Joseph — Liverpool, New York
  • Nyph/Cumc — New York, New York
  • NC Heart and Vascular — Raleigh, North Carolina

📞 Contact the Study Coordinator

Phone: (651) 324-4931

Email: lisa.melchior@bsci.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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 § 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

💡 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.
🏛️ View Official NIH Record ↗