Recruiting

Global ParadiseGlobal Paradise System US Post Approval Study

Sponsor:

ReCor Medical, Inc.

Code:

NCT06297291

Conditions

Hypertension

Cardiovascular Diseases

Vascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paradise Ultrasound Renal Denervation Treatment

Study Details

Brief summary:

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.

Conditions

Hypertension

Cardiovascular Diseases

Vascular Diseases

Study ID

NCT06297291

Start date

Jun 28, 2024

Status verified date

Aug, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Prospective Ultrasound Renal Denervation Treatment

Hypertension patients that meet the eligibility criteria for treatment with Recor Medical Paradise Ultrasound Renal Denervation System will be enrolled and followed post-procedure for 5 years.

RADIANCE CAP Transfer

Subjects enrolled in the RADIANCE Continued Access Protocol (CAP) study that are still active and have already completed their post-procedure 12-month follow-up visit are invited to participate in US GPS for long-term annual follow-up visits. These subjects will have already received the ultrasound Renal Denervation treatment under the RADIANCE CAP protocol and will not receive the procedure under the US GPS protocol.

Interventions

Paradise Ultrasound Renal Denervation Treatment

The Paradise Ultrasound Renal Denervation System (Paradise Ultrasound RDN) is an FDA-approved catheter-based system to treat hypertension by ablating the nerves around the renal arteries, disrupting the overactive sympathetic nerves that can cause high blood pressure. The Paradise procedure uses ultrasound energy to calm the nerves near the kidneys to help lower blood pressure.

Treatment is usually done in an outpatient setting and typically takes about an hour to perform. As a part of the treatment, a small flexible tube (catheter) is guided into the blood vessels near the kidneys and 7 seconds of ultrasound energy is applied 2-3 times. Both sides are treated and then the catheter is removed, leaving nothing behind. After the procedure, some people go home the same day or some stay overnight.

Primary outcome measure

Co-Primary Endpoint #1: Group Mean BP reduction [ Time Frame: Baseline to 3-months post-procedure ]
Co-Primary Endpoint #2: Subject Responder [ Time Frame: Baseline to 3-months post-procedure ]

Central Contacts and Locations

Central contacts

Helen Reeve-Stoffer, PhD

+1 650-912-9032 hreeve-stoffer@recormedical.com

Liz Sheehan

Liz.Sheehan@recormedical.com

Locations

Tibor Rubin VA Medical Center

Recruiting

Long Beach, California, United States, 90822

Contacts

Christine Ma

562-826-8000 Christine.Agas@va.gov

Principal Investigator:

Arnold Seto, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Milagros Gonzalez

424-315-0295 milagros.gonzalez@cshs.org

Principal Investigator:

Florian Rader, MD

Sutter Institute for Medical Research

Recruiting

Sacramento, California, United States, 95816

Contacts

Kimberly Marinovich

Kimberly.Marinovich@sutterhealth.org

Principal Investigator:

Powell Jose, MD

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Cynthia O'Connell

916-734-2197 cloconnell@health.ucdavis.edu

Principal Investigator:

Surabhi Atreja, MD

Pacific Heart Institute

Recruiting

Santa Monica, California, United States, 90404

Contacts

Alette Laughton

424-315-4556 research@pacificheart.com

Principal Investigator:

Michael Broukhim, MD

Rocky Mountain Regional VAMC

Recruiting

Aurora, Colorado, United States, 80045

Contacts

David Korb

720-857-5286 David.Korb@va.gov

Principal Investigator:

Bilal Aijaz, MD

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Contacts

Tyler Lantvit

970-624-1584 Tyler.Lantvit@uchealth.org

Principal Investigator:

Robert Rayson, MD

Bridgeport Hosptial

Recruiting

Bridgeport, Connecticut, United States, 06610

Contacts

Jessica LeBlanc

jessica.leblanc@bpthosp.org;

Principal Investigator:

Edward Tuohy, MD

The Cardiac & Vascular Institute

Recruiting

Gainesville, Florida, United States, 32605

Contacts

Marti Roberson

mroberson@tcavi.com

Principal Investigator:

Matheen Khuddus, MD

University of Miami Health System

Recruiting

Miami, Florida, United States, 33136

Contacts

Bonni Lang

305-243-4950 blang@med.miami.edu

Principal Investigator:

Ioannis Chatzizisis, MD

Ascension Sacred Heart

Recruiting

Pensacola, Florida, United States, 32504

Contacts

Carole Funderburk

850-416-1181 carole.funderburk@ascension.org

Principal Investigator:

Rohit Amin, MD

Tampa Cardiovascular Interventions and Research

Recruiting

Tampa, Florida, United States, 33614

Contacts

Allis Delafield

813-232-0339 adelafieldtcir@gmail.com

Principal Investigator:

Saihari Sadanandan, MD

Wellstar Kennestone Hospital

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Julie Bonds

470-793-4502 julie.bonds@wellstar.org

Principal Investigator:

Summer Aldrugh, MD

Southern Illinois University, Memorial Medical Center

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Katy Martz

kmartz35@siumed.edu

Principal Investigator:

John Flack, MD

Ascension via Christi St. Francis

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Lindsey Steele

316-268-8092 lindsey.steele@ascension.org

Principal Investigator:

Bassem Chehab, MD

Touro Infirmary

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Khahtahvah Joseph

504-702-5174 khahtahvah.joseph@lcmchealth.org

Principal Investigator:

Leonard Glade, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Emily Clausen

617-643-9896 eclausen@mgh.harvard.edu

jgarasic@mgh.harvard.edu

Principal Investigator:

Joseph Garasic, MD

The Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Joanna Samsel

JSAMSEL@mgh.harvard.edu

Principal Investigator:

Naomi Fisher, MD

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Michelle Butcher

586-202-0376 MButche1@hfhs.org

MButche1@hfhs.org

Principal Investigator:

Herbert Aronow, MD

Henry Ford St. John Hospital

Recruiting

Detroit, Michigan, United States, 48236

Contacts

Heather Metcalfe

313-343-7527 hmetcal1@hfhs.org

Principal Investigator:

Amir Kaki, MD

Metropolitan Heart & Vascular Institute

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Derek Vang

763-427-9980 Derek.Vang@mhvi.com

Principal Investigator:

Matthew Whitbeck, MD

Saint Luke's Mid America Heart Institute

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Dana King

ddakon@saint-lukes.org

Principal Investigator:

Steven Laster, MD

Virtua Health

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Kristin Broderick

856-355-1225 KBroderick@virtua.org

Principal Investigator:

Kintur Sanghvi, MD

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Michael Gillogly

518-262-4403 gillogm@amc.edu

Principal Investigator:

Neil Yager, DO

NewYork-Presbyterian Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 11215

Contacts

Sadaf Zalmai

516-952 4304 swo9003@nyp.org

Principal Investigator:

Manish Parikh, MD

University at Buffalo

Recruiting

Buffalo, New York, United States, 14203

Contacts

Lindsay Moshides

716-888-4848 lmoshide@buffalo.edu

Principal Investigator:

Vijay Iyer, MD

NYU Langone Health - Bellevue Hosptial

Recruiting

New York, New York, United States, 10016

Contacts

Natalie Massenburg

natalie.massenburg@nyulangone.org

Principal Investigator:

Sripal Bangalore, MD

Columbia University Medical Center/New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Suzanne Edwards, PhD

sme2146@cumc.columbia.edu

Principal Investigator:

Ajay Kirtane, MD

Stony Brook Medicine

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Ruth Stein

631-444-3309 ruth.stein@stonybrookmedicine.edu

Brianna Rubenstein

631-444-3362 Brianna.Rubenstein@stonybrookmedicine.edu

Principal Investigator:

John Reilly, MD

University of North Carolina at Chapel Hill School of Medicine

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Geri Messinger

919-843-8644 Geri_Messinger@med.unc.edu

Principal Investigator:

George Stouffer, MD

Durham VA Health System

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Kathy Aristy, RN, BSN

919-286-0411 kathy.aristy@va.gov

Principal Investigator:

Jorge Antonio Gutierrez, MD

UPMC Harrisburg

Recruiting

Harrisburg, Pennsylvania, United States, 17110

Contacts

Kathy Retzlaff

717-920-4466 retzlaffkl@upmc.edu

Principal Investigator:

William Bachinsky, MD

Penn Medicine

Recruiting

Phildelphia, Pennsylvania, United States, 19104

Contacts

Anisha Bhandari

215-662-2410 Anisha.Bhandari@PennMedicine.upenn.edu

Principal Investigator:

Debbie Cohen, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Anthony Awkar

awkar@musc.edu

Principal Investigator:

Thomas Todoran, MD

Prisma Health Richland Hospital

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Regina Maharajh

(803) 434-3800 Regina.Maharajh3@prismahealth.org

Principal Investigator:

Vince Vismara, MD

Spartanburg Regional Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

Darla Howard, RN

864-560-1042 dhoward@srhs.com

Principal Investigator:

Brian Brown, MD

Ascension Saint Thomas

Recruiting

Nashville, Tennessee, United States, 37205

Contacts

Amelia Drennan

amelia.drennan@ascension.org

Principal Investigator:

Mark Koenig, MD

Ascension Seton

Recruiting

Austin, Texas, United States, 78705

Contacts

Katherine Lentz

512-324-3434 katherine.lentz@ascension.org

Principal Investigator:

Peter Monteleone, MD

Dallas VAMC

Recruiting

Dallas, Texas, United States, 75216

Contacts

Rema Iskandarani

214-857-3402 Rema.Iskandarani@va.gov

Principal Investigator:

Oladipupo Olafiranye, MD

TCR Institute

Recruiting

Kingwood, Texas, United States, 77339

Contacts

Fielicia Stowe

fielicia.stowe@tcrinstitute.com

Principal Investigator:

Marloe Prince, MD

St. Mark's Hospital

Recruiting

Salt Lake City, Utah, United States, 84124

Contacts

Pragyna Gundaboina

801-518-1326 Pragyna.Gundaboina@hcahealthcare.com

Principal Investigator:

Vamsee Yaganti, MD

Inova Fairfax Hospital

Recruiting

Fairfax, Virginia, United States, 22042

Contacts

Diana McLean

diana.mclean@inova.org

Principal Investigator:

Benham Tehrani, MD

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

Serena Risher

206-320-8283 serena.risher@swedish.org

Principal Investigator:

Paul Huang, MD

More Information

Sponsor

ReCor Medical, Inc.

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

Blood Pressure
Uncontrolled Hypertension
Essential Hypertension
Resistant Hypertension
Renal Denervation
Ultrasound Renal Denervation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by ReCor Medical, Inc. on 2026-08-12.