Clinical trialNCT06559891RecruitingInterventional

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

SponsorSoniVie Inc.Enrollment261Hypertension

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Ajay Kirtane, MD
Columbia University
Study ChairKOL profile →
clinicaltrials.gov ↗
Felix Mahfoud, MD
University of Basel
Study Chair
clinicaltrials.gov ↗
Michel Azizi, MD
George Pompidou Hospital
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

50 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

France

Hopital Saint André
Bordeaux, France
Recruiting
Hôpital Européen Georges-Pompidou
Paris, France
Recruiting

Germany

Dresden Tud University of Technology
Dresden, Germany
Recruiting
Universitätsklinikum Erlangen
Erlangen, Germany
Recruiting
Frankfurt Sankt Katharinen Krankenhaus
Frankfurt, Germany
Recruiting
Freiburg Herzzenrtum
Freiburg im Breisgau, Germany
Recruiting
Marienkrankenhaus Hamburg
Hamburg, Germany
Recruiting
Herne Marien Hospital
Herne, Germany
Recruiting
Saarland University Hospital
Homburg, Germany
Recruiting
Herzzentrum Leipzig
Leipzig, Germany
Recruiting
Sana Kliniken Lubeck
Lübeck, Germany
Recruiting

Greece

Athens Hippokration
Athens, Greece
Recruiting
University of Crete
Heraklion, Greece
Recruiting
Thessaloniki Hippokration General Hospital
Thessaloniki, Greece
Recruiting

Italy

Clinica Montevergine
Mercogliano, Italy
Recruiting
Monza Policlinico
Monza, Italy
Recruiting
Ospedale Sant'Andrea
Roma, Italy
Recruiting

United States

Cardiology, Pc
Birmingham, Alabama, United States
Farrell O Mendelsohn
Recruiting
Honorhealth
Scottsdale, Arizona, United States
Recruiting
St. Bernard'S Medical Center
Jonesboro, Arkansas, United States
Recruiting
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Recruiting
Cedar-Sinai Medical Center
Los Angeles, California, United States
Recruiting
Stanford University
Palo Alto, California, United States
Recruiting
Connecticut Clinical Research, Llc (bridgeport)
Bridgeport, Connecticut, United States
Recruiting
Ascension- Sacred Heart
Pensecola, Florida, United States
Recruiting
University of South Florida
Tampa, Florida, United States
Recruiting
Ascension Alexian Brothers
Elk Grove Village, Illinois, United States
Alexander Fraley, M.D.
Recruiting
Southern Illinois University, School of Medicine
Springfield, Illinois, United States
Recruiting
St. John'S Prairie Heart
Springfield, Illinois, United States
Recruiting
Cardiovascular Institute of the South
Houma, Louisiana, United States
Recruiting
Ochsner Medical Center
New Orleans, Louisiana, United States
Recruiting
Henry Ford Hospital
Detroit, Michigan, United States
Recruiting
Henry Ford Providence Hospital
Southfield, Michigan, United States
Recruiting
Gulfport Memorial Hospital
Gulfport, Mississippi, United States
Recruiting
Jackson Heart Clinic
Jackson, Mississippi, United States
Recruiting
St Lukes Hospital
Kansas City, Missouri, United States
Recruiting
Renown Regional Medical Center
Reno, Nevada, United States
Recruiting
Virtua Health
Camden, New Jersey, United States
Recruiting
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Recruiting
St. Joseph
Liverpool, New York, United States
Recruiting

10 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 3 Oct 2024
Primary completion: 31 Mar 2027
Completion: 15 Aug 2028
Last update posted: 3 Aug 2026
Registered enrollment: 261
Registry id: NCT06559891

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.