Actively Recruiting
THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
Led by SoniVie Inc. · Updated on 2026-05-05
261
Participants Needed
50
Research Sites
201 weeks
Total Duration
On this page
Sponsors
S
SoniVie Inc.
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Adults aged 22 to 75 years
- Documented history of hypertension
- Previously or currently prescribed antihypertensive therapy
- Office blood pressure at screening of either uncontrolled (140/90 to <180/110 mmHg) on 0-2 anti-hypertensive drugs or controlled (<140/90 mmHg) on 1-2 anti-hypertensive drugs
- Willing to stop anti-hypertensive medications for 4 weeks before and 2 months after procedure
- Able and willing to comply with study procedures
- Candidate for conscious sedation
- Documented daytime systolic ambulatory blood pressure ≥135 mmHg and <180 mmHg after 4-week washout/run-in
- Suitable renal anatomy confirmed by imaging within 1 year
You will not qualify if you...
- Abnormal renal artery or kidney anatomy (e.g., single kidney, polycystic kidney disease, tumors)
- Uncorrected secondary hypertension causes excluding sleep apnea
- Type I diabetes or uncontrolled Type II diabetes (HbA1c ≥9.0%)
- Estimated glomerular filtration rate (eGFR) <40 mL/min/1.73 m2
- Stroke or cerebrovascular event within 6 months
- Severe cardiovascular events within 12 months (e.g., myocardial infarction, acute heart failure NYHA III-IV)
- Severe valvular heart disease
- Multiple or recent hospitalizations for hypertensive crisis
- Use of cardiovascular medications that cannot be stopped safely
- Rapid, uncontrolled symptomatic atrial fibrillation
- Active implantable medical devices
- Chronic oxygen or mechanical ventilation support except nocturnal for sleep apnea
- Planned major surgery requiring general anesthesia within 12 months
- Anticoagulant therapy that cannot be paused
- Primary pulmonary hypertension
- Allergy or contraindication to contrast medium
- Life expectancy under 1 year
- Night shift worker
- Frequent use of NSAIDs for pain
- Immunosuppressive therapy for vasculitis
- History of drug or alcohol dependency or inability to comply with study
- Pregnant, nursing, or planning pregnancy within 12 months
- Planned major surgery or cardiovascular intervention within 6 months
- History of renal transplantation
- Active infection within 7 days of procedure
- Hypertrophic cardiomyopathy or amyloidosis
- Prior renal denervation procedure
- Concurrent participation in other investigational drug or device trials
- Use of beta blockers for conditions other than hypertension
- Specific angiographic renal artery criteria excluding participants (e.g., artery diameter <4 mm, artery length <20 mm, significant artery abnormalities or stenosis)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 50 locations
1
Cardiology, PC
Birmingham, Alabama, United States, 35211
Actively Recruiting
2
Honor Health Research Institue
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
St. Bernard's Medical Center
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
4
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
Actively Recruiting
5
Cedar-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
6
Stanford University
Palo Alto, California, United States, 94305
Actively Recruiting
7
Bridgeport
Bridgeport, Connecticut, United States, 06610
Actively Recruiting
8
Ascension- Sacred Heart
Pensecola, Florida, United States, 32504
Actively Recruiting
9
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
10
Ascension Alexian Brothers
Elk Grove Village, Illinois, United States, 60007
Actively Recruiting
11
St. John's Prairie Heart
Springfield, Illinois, United States, 62710
Actively Recruiting
12
Southern Illinois University, School of Medicine
Springfield, Illinois, United States, 62794
Actively Recruiting
13
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
14
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Actively Recruiting
15
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
16
Henry Ford Providence Hospital
Southfield, Michigan, United States, 48075
Actively Recruiting
17
Gulfport Memorial Hospital
Gulfport, Mississippi, United States, 39501
Actively Recruiting
18
Jackson Heart
Jackson, Mississippi, United States, 39216
Actively Recruiting
19
St Lukes Hospital
Kansas City, Missouri, United States, 64131
Actively Recruiting
20
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
21
Virtua Health
Camden, New Jersey, United States, 08103
Actively Recruiting
22
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
23
St. Joseph
Liverpool, New York, United States, 13088
Actively Recruiting
24
Nyph/Cumc
New York, New York, United States, 10032
Actively Recruiting
25
NC Heart and Vascular
Raleigh, North Carolina, United States, 27607
Actively Recruiting
26
Ascension St. John Clinical Research Institute
Bartlesville, Oklahoma, United States, 74006
Actively Recruiting
27
Lancaster General Health
Lancaster, Pennsylvania, United States, 17603
Actively Recruiting
28
Penn Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
29
MUSC
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
30
Medical City
Fort Worth, Texas, United States, 76104
Actively Recruiting
31
Houston Medical Center
Houston, Texas, United States, 77004
Actively Recruiting
32
St Marks Hospital
Salt Lake City, Utah, United States, 37027
Actively Recruiting
33
Chippenham Hospital
Richmond, Virginia, United States, 23225
Actively Recruiting
34
Hopital Saint André
Bordeaux, France
Actively Recruiting
35
Hôpital Européen Georges-Pompidou
Paris, France
Actively Recruiting
36
Dresden TUD University of Technology
Dresden, Germany
Actively Recruiting
37
Universitätsklinikum Erlangen
Erlangen, Germany
Actively Recruiting
38
Frankfurt Sankt Katharinen Krankenhaus
Frankfurt, Germany
Actively Recruiting
39
Freiburg Herzzenrtum
Freiburg im Breisgau, Germany
Actively Recruiting
40
Marienkrankenhaus Hamburg
Hamburg, Germany
Actively Recruiting
41
Herne Marien Hospital
Herne, Germany
Actively Recruiting
42
Saarland University Hospital
Homburg, Germany
Actively Recruiting
43
Herzzentrum Leipzig
Leipzig, Germany
Actively Recruiting
44
Sana Kliniken Lubeck
Lübeck, Germany
Actively Recruiting
45
Athens Hippokration
Athens, Greece
Actively Recruiting
46
University of Crete
Heraklion, Greece
Actively Recruiting
47
Thessaloniki Hippokration General Hospital
Thessaloniki, Greece
Actively Recruiting
48
Clinica Montevergine
Mercogliano, Italy
Actively Recruiting
49
Monza Policlinico
Monza, Italy
Actively Recruiting
50
Ospedale Sant'Andrea
Roma, Italy
Actively Recruiting
Research Team
L
Lisa Melchior
CONTACT
J
Janelle Noble
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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