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Global Paradise System US Post Approval Study

RecruitingObservational study

The Global Paradise® System US Post Approval Study (US GPS)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Signed and dated study informed consent
* Documented history of hypertension
* Documented history of prior or current antihypertensive medication(s)
* Mean seated office systolic BP at screening ≥ 140 mmHg
* Mean pre-procedure home systolic BP of ≥ 135 mmHg
* Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2

RADIANCE CAP patients must provide signed and dated informed consent for inclusion in long-term follow-up. No other criteria are required for inclusion.

Exclusion Criteria:

Patients who meet the following will be excluded from participation:

* Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter
* Patient under the age of 18 years old at the time of consent
* Patient is pregnant
* Patients with transplanted kidney
* Presence of abnormal kidney (or secreting adrenal) tumors

To confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment:

* Renal arteries with diameter \< 3mm and \> 8mm
* Renal artery with fibromuscular dysplasia (FMD)
* Stented renal artery
* Renal artery aneurysm
* Renal artery diameter stenosis \>30%
* Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter

About the study

The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.

What is being tested

Sponsor: ReCor Medical, Inc. · Participants: 1,000 · Started: Jun 28, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06297291

Locations in the U.S.

CaliforniaTibor Rubin VA Medical Center, Long Beach
Cedars-Sinai Medical Center, Los Angeles
Sutter Institute for Medical Research, Sacramento
UC Davis Medical Center, Sacramento
Pacific Heart Institute, Santa Monica
ColoradoRocky Mountain Regional VAMC, Aurora
Medical Center of the Rockies, Loveland
ConnecticutBridgeport Hosptial, Bridgeport
FloridaThe Cardiac & Vascular Institute, Gainesville
University of Miami Health System, Miami
Ascension Sacred Heart, Pensacola
Tampa Cardiovascular Interventions and Research, Tampa
GeorgiaWellstar Kennestone Hospital, Marietta
IllinoisSouthern Illinois University, Memorial Medical Center, Springfield
KansasAscension via Christi St. Francis, Wichita
LouisianaTouro Infirmary, New Orleans
MassachusettsMassachusetts General Hospital, Boston
The Brigham and Women's Hospital, Boston
MichiganHenry Ford Health, Detroit
Henry Ford St. John Hospital, Detroit
MinnesotaMetropolitan Heart & Vascular Institute, Coon Rapids
MissouriSaint Luke's Mid America Heart Institute, Kansas City
New JerseyVirtua Health, Marlton
New YorkAlbany Medical Center, Albany
NewYork-Presbyterian Brooklyn Methodist Hospital, Brooklyn
University at Buffalo, Buffalo
Columbia University Medical Center/New York Presbyterian Hospital, New York
NYU Langone Health - Bellevue Hosptial, New York
Stony Brook Medicine, Stony Brook
North CarolinaUniversity of North Carolina at Chapel Hill School of Medicine, Chapel Hill
Durham VA Health System, Durham
PennsylvaniaUPMC Harrisburg, Harrisburg
Penn Medicine, Phildelphia
South CarolinaMedical University of South Carolina, Charleston
Prisma Health Richland Hospital, Columbia
Spartanburg Regional Medical Center, Spartanburg
TennesseeAscension Saint Thomas, Nashville
TexasAscension Seton, Austin
Dallas VAMC, Dallas
TCR Institute, Kingwood
UtahSt. Mark's Hospital, Salt Lake City
VirginiaInova Fairfax Hospital, Fairfax
WashingtonSwedish Medical Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.