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)

Status: Recruiting
Location: See all (44) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ Appropriately signed and dated informed consent

⁃ Male and female adults with age between ≥22 and ≤75 years at time of consent

⁃ Documented history of hypertension

⁃ Previously or currently prescribed antihypertensive therapy

⁃ Subject has an office BP (average of 3 seated measurements) of:

• Uncontrolled BP: ≥ 140/90 mmHg \<180/110 mmHg at Screening Visit (V0) while stable for at least 4 weeks on 0-2 anti-hypertensive medications of different classes\* and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure, (subjects with a history of treatment with anti-hypertensive medications but are not currently taking any at screening will undergo a 4-week run-in period) or,

∙ Controlled BP: \< 140/90 mmHg while stable for at least 4 weeks on 1-2 antihypertensive medications of different classes and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure

⁃ Able and willing to comply with all study procedures

⁃ Subject is willing to have and is a good candidate for conscious sedation

⁃ Subjects who meet the following criteria will be considered eligible for randomization:

• Documented daytime systolic ABP ≥ 135 mmHg and \< 180 mmHg after 4-week washout/run-in period.\*\*

• Suitable renal anatomy compatible with the renal denervation procedure, documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in subjects without a recent (≤1 year) cross-sectional renal imaging). The renal angiogram procedure done in the cath lab prior to randomization will serve as the final anatomy compatibility check.

‣ Potassium-sparing diuretics such as Amiloride hydrochloride and Triamterene may be prescribed in combination with another diuretic (e.g. a thiazide or loop diuretic) for their potassium conservation properties. In this situation, the diuretic combination is considered as a single class of anti-hypertensive.

Locations
United States
Alabama
Cardiology, PC
RECRUITING
Birmingham
Arkansas
St. Bernard's Medical Center
RECRUITING
Jonesboro
Arkansas Heart Hospital
RECRUITING
Little Rock
Arizona
Honor Health Research Institue
RECRUITING
Scottsdale
California
Cedar-Sinai Medical Center
RECRUITING
Los Angeles
Stanford University
RECRUITING
Stanford
Connecticut
Bridgeport
RECRUITING
Bridgeport
Florida
Ascension- Sacred Heart
RECRUITING
Pensecola
University of South Florida
RECRUITING
Tampa
Illinois
Ascension Alexian Brothers
RECRUITING
Elk Grove Village
Southern Illinois University, School of Medicine
RECRUITING
Springfield
St. John's Prairie Heart
RECRUITING
Springfield
Louisiana
Cardiovascular Institute of the South
RECRUITING
Houma
Ochsner Medical Center
RECRUITING
New Orleans
Michigan
Henry Ford Hospital
RECRUITING
Detroit
Henry Ford Providence Hospital
RECRUITING
Southfield
Missouri
St Lukes Hospital
RECRUITING
Kansas City
St. Luke's Hospital
RECRUITING
Kansas City
Mississippi
Gulfport Memorial Hospital
RECRUITING
Gulfport
Jackson Heart
RECRUITING
Jackson
North Carolina
NC Heart and Vascular
RECRUITING
Raleigh
New Jersey
Virtua Health
RECRUITING
Camden
Jersey Shore University Medical Center
RECRUITING
Neptune City
Nevada
Renown Regional Medical Center
RECRUITING
Reno
New York
Nyph/Cumc
RECRUITING
New York
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Texas
Medical City
RECRUITING
Fort Worth
Houston Medical Center
RECRUITING
Houston
Utah
St Marks Hospital
RECRUITING
Salt Lake City
Virginia
Chippenham Hospital
RECRUITING
Richmond
Other Locations
France
Hopital Saint André
RECRUITING
Bordeaux
Hôpital Européen Georges-Pompidou
RECRUITING
Paris
Germany
Universitätsklinikum Erlangen
RECRUITING
Erlangen
Frankfurt Sankt Katharinen Krankenhaus
RECRUITING
Frankfurt
Freiburg Herzzenrtum
RECRUITING
Freiburg Im Breisgau
Marienkrankenhaus Hamburg
RECRUITING
Hamburg
Herne Marien Hospital
RECRUITING
Herne
Herzzentrum Leipzig
RECRUITING
Leipzig
Sana Kliniken Lubeck
RECRUITING
Lübeck
Greece
Athens Hippokration
RECRUITING
Athens
University of Crete
RECRUITING
Heraklion
Thessaloniki Hippokration General Hospital
RECRUITING
Thessaloniki
Italy
Clinica Montevergine
RECRUITING
Mercogliano
Ospedale Sant'Andrea
RECRUITING
Roma
Contact Information
Primary
Lisa Melchior
lisa.melchior@bsci.com
651-324-4931
Backup
Janelle Noble
janelle.noble@bsci.com
612-598-4368
Time Frame
Start Date: 2024-10-03
Estimated Completion Date: 2028-08-15
Participants
Target number of participants: 261
Treatments
Experimental: TIVUS™ Renal Denervation System
Following angiogram, subjects found anatomically eligible and randomized to the renal denervation arm will be treated with the TIVUS™ Renal Denervation System.
Sham_comparator: Sham
For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.
Related Therapeutic Areas
Sponsors
Collaborators: NAMSA, European Cardiovascular Research Center
Leads: SoniVie Inc.

This content was sourced from clinicaltrials.gov