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HypertensionUS GPSNCT06297291

Global Paradise System US Post Approval Study

An observational study of Hypertension and Cardiovascular Diseases, run by ReCor Medical, Inc. at 46 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Paradise Ultrasound Renal Denervation Treatment
Type of treatment
Medical device
How many people
1,000 participants
Where
46 sitesUnited States
Study dates
28 Jun 2024to Jul 2031
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control BP will be identified from the general population by the enrolling center. Subjects enrolled in the RADIANCE CAP study will be transferred to the US GPS study after completion of their 12-month follow-up visit in the RADIANCE CAP study, to complete the remainder of the long-term annual follow-up visits under the post approval study protocol.

Who may be able to join

  • Signed and dated study informed consent
  • Documented history of hypertension
  • Documented history of prior or current antihypertensive medication(s)
  • Baseline 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.

Who cannot join

  • Patients who meet the following will be excluded from participation:
  • Subject under the age of 18 years old at the time of consent
  • Subject is pregnant prior to index procedure^ ^ If a treated subject becomes pregnant after ultrasound RDN procedure, the subject will be followed for outcomes.
  • The ultrasound RDN procedure will be performed according to the IFU for the Paradise System and per the site's standard of care for interventional Procedures.

Trial locations and contacts

46 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Helen Reeve-Stoffer, PhD contact

+1 650-912-9032

hreeve-stoffer@recormedical.com

Liz Sheehan contact

Liz.Sheehan@recormedical.com

46 sites in 1 country

United States46 sites, 46 recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Michael Gillogly, 518-262-4403, gillogm@amc.edu

    Neil Yager, DO

    Recruiting

  • Rocky Mountain Regional VAMC

    Aurora, Colorado, 80045

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

    Bilal Aijaz, MD

    Recruiting

  • Ascension Seton

    Austin, Texas, 78705

    Katherine Lentz, 512-324-3434, katherine.lentz@ascension.org

    Peter Monteleone, MD

    Recruiting

  • St. Luke's Regional Medical Center

    Boise, Idaho, 83712

    Cecelia Pena, 208-388-7519, penace@slhs.org

    Edward Terrien, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Emily Clausen, 617-643-9896, eclausen@mgh.harvard.edu

    jgarasic@mgh.harvard.edu

    Recruiting

  • The Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Joanna Samsel, JSAMSEL@mgh.harvard.edu

    Naomi Fisher, MD

    Recruiting

  • Bridgeport Hosptial

    Bridgeport, Connecticut, 06610

    Jessica LeBlanc, jessica.leblanc@bpthosp.org;

    Edward Tuohy, MD

    Recruiting

  • NewYork-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    Sadaf Zalmai, 516-952 4304, swo9003@nyp.org

    Manish Parikh, MD

    Recruiting

  • University at Buffalo

    Buffalo, New York, 14203

    Lindsay Moshides, 716-888-4848, lmoshide@buffalo.edu

    Vijay Iyer, MD

    Recruiting

  • University of North Carolina at Chapel Hill School of Medicine

    Chapel Hill, North Carolina, 27599

    Geri Messinger, 919-843-8644, Geri_Messinger@med.unc.edu

    George Stouffer, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Anthony Awkar, awkar@musc.edu

    Thomas Todoran, MD

    Recruiting

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203

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

    Vince Vismara, MD

    Recruiting

  • Metropolitan Heart & Vascular Institute

    Coon Rapids, Minnesota, 55433

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

    Matthew Whitbeck, MD

    Recruiting

  • Dallas VAMC

    Dallas, Texas, 75216

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

    Oladipupo Olafiranye, MD

    Recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Michelle Butcher, 586-202-0376, MButche1@hfhs.org

    MButche1@hfhs.org

    Recruiting

  • Henry Ford St. John Hospital

    Detroit, Michigan, 48236

    Heather Metcalfe, 313-343-7527, hmetcal1@hfhs.org

    Amir Kaki, MD

    Recruiting

  • Durham VA Health System

    Durham, North Carolina, 27705

    Kathy Aristy, RN, BSN, 919-286-0411 ext. 17-5222, kathy.aristy@va.gov

    Jorge Antonio Gutierrez, MD

    Recruiting

  • AHN Saint Vincent

    Erie, Pennsylvania, 16502

    Brandi Vanerstorm, 814-453-7767 ext. 2315

    Orestis Pappas, MD

    Recruiting

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22042

    Diana McLean, diana.mclean@inova.org

    Benham Tehrani, MD

    Recruiting

  • The Cardiac & Vascular Institute

    Gainesville, Florida, 32605

    Marti Roberson, mroberson@tcavi.com

    Matheen Khuddus, MD

    Recruiting

  • UPMC Harrisburg

    Harrisburg, Pennsylvania, 17110

    Kathy Retzlaff, 717-920-4466, retzlaffkl@upmc.edu

    William Bachinsky, MD

    Recruiting

  • Saint Luke's Mid America Heart Institute

    Kansas City, Missouri, 64111

    Dana King, ddakon@saint-lukes.org

    Steven Laster, MD

    Recruiting

  • TCR Institute

    Kingwood, Texas, 77339

    Fielicia Stowe, fielicia.stowe@tcrinstitute.com

    Marloe Prince, MD

    Recruiting

  • Tibor Rubin VA Medical Center

    Long Beach, California, 90822

    Christine Ma, 562-826-8000 ext. 1-2889, Christine.Agas@va.gov

    Arnold Seto, MD

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Milagros Gonzalez, 424-315-0295, milagros.gonzalez@cshs.org

    Florian Rader, MD

    Recruiting

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

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

    Robert Rayson, MD

    Recruiting

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

    Julie Bonds, 470-793-4502, julie.bonds@wellstar.org

    Summer Aldrugh, MD

    Recruiting

  • Virtua Health

    Marlton, New Jersey, 08053

    Kristin Broderick, 856-355-1225, KBroderick@virtua.org

    Kintur Sanghvi, MD

    Recruiting

  • University of Miami Health System

    Miami, Florida, 33136

    Bonni Lang, 305-243-4950, blang@med.miami.edu

    Ioannis Chatzizisis, MD

    Recruiting

  • Ascension Saint Thomas

    Nashville, Tennessee, 37205

    Amelia Drennan, amelia.drennan@ascension.org

    Mark Koenig, MD

    Recruiting

  • Touro Infirmary

    New Orleans, Louisiana, 70112

    Khahtahvah Joseph, 504-702-5174, khahtahvah.joseph@lcmchealth.org

    Leonard Glade, MD

    Recruiting

  • NYU Langone Health - Bellevue Hosptial

    New York, New York, 10016

    Natalie Massenburg, natalie.massenburg@nyulangone.org

    Sripal Bangalore, MD

    Recruiting

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032

    Suzanne Edwards, PhD, sme2146@cumc.columbia.edu

    Ajay Kirtane, MD

    Recruiting

  • Ascension Sacred Heart

    Pensacola, Florida, 32504

    Carole Funderburk, 850-416-1181, carole.funderburk@ascension.org

    Rohit Amin, MD

    Recruiting

  • Penn Medicine

    Phildelphia, Pennsylvania, 19104

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

    Debbie Cohen, MD

    Recruiting

  • WakeMed Health and Hospitals

    Raleigh, North Carolina, 27610

    Macy Goodson, (919) 350-1184, 919-350-1183

    Pratik Desai, MD

    Recruiting

  • Sutter Institute for Medical Research

    Sacramento, California, 95816

    Kimberly Marinovich, Kimberly.Marinovich@sutterhealth.org

    Powell Jose, MD

    Recruiting

  • UC Davis Medical Center

    Sacramento, California, 95817

    Cynthia O'Connell, 916-734-2197, cloconnell@health.ucdavis.edu

    Surabhi Atreja, MD

    Recruiting

  • St. Mark's Hospital

    Salt Lake City, Utah, 84124

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

    Vamsee Yaganti, MD

    Recruiting

  • Pacific Heart Institute

    Santa Monica, California, 90404

    Alette Laughton, 424-315-4556, research@pacificheart.com

    Michael Broukhim, MD

    Recruiting

  • Swedish Medical Center

    Seattle, Washington, 98122

    Serena Risher, 206-320-8283, serena.risher@swedish.org

    Paul Huang, MD

    Recruiting

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

    Darla Howard, RN, 864-560-1042, dhoward@srhs.com

    Brian Brown, MD

    Recruiting

  • Southern Illinois University, Memorial Medical Center

    Springfield, Illinois, 62702

    Katy Martz, kmartz35@siumed.edu

    John Flack, MD

    Recruiting

  • Stony Brook Medicine

    Stony Brook, New York, 11794

    Ruth Stein, 631-444-3309, ruth.stein@stonybrookmedicine.edu

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

    Recruiting

  • Tampa Cardiovascular Interventions and Research

    Tampa, Florida, 33614

    Allis Delafield, 813-232-0339, adelafieldtcir@gmail.com

    Saihari Sadanandan, MD

    Recruiting

  • Ascension via Christi St. Francis

    Wichita, Kansas, 67214

    Lindsey Steele, 316-268-8092, lindsey.steele@ascension.org

    Bassem Chehab, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

In some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys are overactive, which may cause blood pressure to increase. Renal denervation is a procedure where a catheter is placed inside these blood vessels and heat is used to ablate and disable the nerve activity and lower blood pressure.

Hypertension patients that meet the study eligibility criteria will undergo the ultrasound renal denervation procedure using the Paradise System and will be asked to measure their blood pressure throughout the study, including measuring BP out of the clinic setting using a home BP monitoring device provided by the study. Participants will also be asked to answer some questions about their quality of life, health, sleep and emotions. Additional demographic data, medical history and socio-economic data may also be collected. As part of study participation, everyone who receives ultrasound renal denervation will be seen by the study doctor and designated study team members for 60 months (5 years) following the procedure.

Being tested
Paradise Ultrasound Renal Denervation Treatment
Keywords
Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Renal Denervation, Ultrasound Renal Denervation
Medical subject headings
Hypertension, Cardiovascular Diseases, Vascular Diseases, Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paradise Ultrasound Renal Denervation TreatmentDevice

    Also called Paradise Ultrasound RDN

    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.

Study groups in NCT06297291
Study groupRoleWhat they receive
Prospective Ultrasound Renal Denervation TreatmentHypertension 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.
Receives: Device: Paradise Ultrasound Renal Denervation Treatment
RADIANCE CAP TransferSubjects 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Co-Primary Endpoint #1: Group Mean BP reduction

    • Ho: Reduction in mean home systolic BP from baseline to 3 months < 5 mmHg
    • Ha: Reduction in mean home systolic BP from baseline to 3 months ≥ 5 mmHg

    Measured: Baseline to 3-months post-procedure

  2. Co-Primary Endpoint #2: Subject Responder

    A subject will be defined as a responder if they achieve any of the following:

    • Control in home BP (defined as systolic BP <130 mmHg) at 3 months and/or
    • Absolute reduction in home systolic BP fall ≥ 5 mmHg at 3 months and/or
    • Reduction in medication burden measured using defined daily dose (DDD)

    Measured: Baseline to 3-months post-procedure

Secondary outcomes (9)

  1. Change in mean home systolic/diastolic BP in mmHg

    Measured: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  2. Change in mean office systolic/diastolic BP in mmHg

    Measured: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  3. Change in home and office pulse pressure

    Measured: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  4. Change in the number and/or dosage and/or type of antihypertensive medications taken

    Measured: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  5. Change in patient reported outcomes

    Measured: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  6. Percentage of patients who are controlled as measured by various cut points of home BP (control to be assessed as both < 130 mmHg systolic and <135 mmHg systolic) office BP (control to also be assessed as <130 mmHg and <140 mmHg systolic)

    Measured: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  7. Percentage of patients who demonstrate a reduction in home systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg

    Measured: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]

  8. Percentage of patients who demonstrate a reduction in office systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg

    Measured: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]

  9. Change in home and office heart rate

    Measured: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study start28 Jun 2024
  3. Primary completionDec 2028 (estimated)
  4. Study completionJul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06297291
Sponsor's protocol ID
CLN 0984
Acronym
US GPS
Status last verified
Oct 2026
First submitted
29 Feb 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Cardiovascular Diseases, run by ReCor Medical, Inc. at 46 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Helen Reeve-Stoffer, PhD (+1 650-912-9032, hreeve-stoffer@recormedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Co-Primary Endpoint #1: Group Mean BP reduction (time frame: Baseline to 3-months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06297291.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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