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NCT06559891 · ClinicalTrials.gov registry record · NA
THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
A NA study of Hypertension, sponsored by SoniVie.
- Recruiting
- Registry status
- NA
- Development phase
- 261
- Enrollment target
- 20
- Study locations
NCT06559891 is a NA study of Hypertension that is actively recruiting participants, run by SoniVie. The registered enrollment target is 261 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT06559891, a NA study of Hypertension, is actively recruiting participants, sponsored by SoniVie.
- RECRUITING
- Registry status
- NA
- Development phase
- 261 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 hypertension (HTN) receiving up to 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 up to 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
Conditions Studied
Interventions
- OTHER Sham
- DEVICE TIVUS™ Renal Denervation System
Study Locations (20)
Illinois
- Ascension Alexian Brothers - Elk Grove Village
- St. John's Prairie Heart - Springfield
- Southern Illinois University, School of Medicine - Springfield
Arkansas
- St. Bernard's Medical Center - Jonesboro
- Arkansas Heart Hospital - Little Rock
California
- Cedar-Sinai Medical Center - Los Angeles
- Stanford University - Stanford
Florida
- Ascension- Sacred Heart - Pensecola
- University of South Florida - Tampa
Louisiana
- Cardiovascular Institute of the South - Houma
- Ochsner Medical Center - New Orleans
Michigan
- Henry Ford Hospital - Detroit
- Henry Ford Providence Hospital - Southfield
Mississippi
- Gulfport Memorial Hospital - Gulfport
- Jackson Heart - Jackson
Missouri
- St. Luke's Hospital - Kansas City
- St Lukes Hospital - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2024-10-03 |
| Est. Completion | 2028-08-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06559891
The ClinicalTrials.gov registry entry for NCT06559891 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 261 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (93% lower). The listed sponsor is SoniVie, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Sham is the first listed.
NCT06559891 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Illinois, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT06559891 about?
NCT06559891 is a clinical study titled "THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension". 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 hypertension (HTN) receiving up to 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a ...
What is the current status of trial NCT06559891?
This trial is currently recruiting. It is a NA study. The enrollment target is 261 participants. The study started on 2024-10-03. Estimated completion is 2028-08-15.
What conditions does trial NCT06559891 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT06559891?
The interventions under investigation include: Sham (OTHER), TIVUS™ Renal Denervation System (DEVICE).
Who is sponsoring clinical trial NCT06559891?
This trial is sponsored by SoniVie, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06559891 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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