Global Paradise System US Post Approval Study (US GPS)

May 1, 2026 updated by: ReCor Medical, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center
        • Contact:
        • Principal Investigator:
          • Surabhi Atreja, MD
      • Sacramento, California, United States, 95816
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Pacific Heart Institute
        • Contact:
        • Principal Investigator:
          • Michael Broukhim, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Rocky Mountain Regional VAMC
        • Contact:
        • Principal Investigator:
          • Bilal Aijaz, MD
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
    • Florida
      • Gainesville, Florida, United States, 32605
        • Recruiting
        • The Cardiac & Vascular Institute
        • Principal Investigator:
          • Matheen Khuddus, MD
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Health System
        • Contact:
        • Principal Investigator:
          • Ioannis Chatzizisis, MD
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Ascension Sacred Heart
        • Principal Investigator:
          • Rohit Amin, MD
        • Contact:
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Tampa Cardiovascular Interventions and Research
        • Principal Investigator:
          • Saihari Sadanandan, MD
        • Contact:
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Wellstar Kennestone Hospital
        • Contact:
        • Principal Investigator:
          • Summer Aldrugh, MD
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University, Memorial Medical Center
        • Principal Investigator:
          • John Flack, MD
        • Contact:
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Ascension Via Christi St. Francis
        • Principal Investigator:
          • Bassem Chehab, MD
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Touro Infirmary
        • Contact:
        • Principal Investigator:
          • Leonard Glade, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • The Brigham and Women's Hospital
        • Principal Investigator:
          • Naomi Fisher, MD
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Principal Investigator:
          • Herbert Aronow, MD
        • Contact:
        • Contact:
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Metropolitan Heart & Vascular Institute
        • Principal Investigator:
          • Matthew Whitbeck, MD
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Mid America Heart Institute
        • Contact:
        • Principal Investigator:
          • Steven Laster, MD
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Virtua Health
        • Contact:
        • Principal Investigator:
          • Kintur Sanghvi, MD
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
        • Principal Investigator:
          • Neil Yager, DO
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • NewYork-Presbyterian Brooklyn Methodist Hospital
        • Principal Investigator:
          • Manish Parikh, MD
        • Contact:
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo
        • Principal Investigator:
          • Vijay Iyer, MD
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/New York Presbyterian Hospital
        • Principal Investigator:
          • Ajay Kirtane, MD
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health - Bellevue Hosptial
        • Contact:
        • Principal Investigator:
          • Sripal Bangalore, MD
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill School of Medicine
        • Contact:
        • Principal Investigator:
          • George Stouffer, MD
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Durham VA Health System
        • Principal Investigator:
          • Jorge Antonio Gutierrez, MD
        • Contact:
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Recruiting
        • UPMC Harrisburg
        • Principal Investigator:
          • William Bachinsky, MD
        • Contact:
      • Phildelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Thomas Todoran, MD
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • Prisma Health Richland Hospital
        • Principal Investigator:
          • Vince Vismara, MD
        • Contact:
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Regional Medical Center
        • Principal Investigator:
          • Brian Brown, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Ascension Seton
        • Principal Investigator:
          • Peter Monteleone, MD
        • Contact:
      • Dallas, Texas, United States, 75216
        • Recruiting
        • Dallas VAMC
        • Principal Investigator:
          • Oladipupo Olafiranye, MD
        • Contact:
      • Kingwood, Texas, United States, 77339
    • Utah
      • Salt Lake City, Utah, United States, 84124
    • Virginia
      • Fairfax, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Hospital
        • Contact:
        • Principal Investigator:
          • Benham Tehrani, MD
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
        • Contact:
        • Principal Investigator:
          • Paul Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: 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.

Other Names:
  • Paradise Ultrasound RDN
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co-Primary Endpoint #1: Group Mean BP reduction
Time Frame: Baseline to 3-months post-procedure
  • 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
Baseline to 3-months post-procedure
Co-Primary Endpoint #2: Subject Responder
Time Frame: Baseline to 3-months post-procedure

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)
Baseline to 3-months post-procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in mean home systolic/diastolic BP in mmHg
Time Frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Change in mean office systolic/diastolic BP in mmHg
Time Frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Change in home and office pulse pressure
Time Frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Change in the number and/or dosage and/or type of antihypertensive medications taken
Time Frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Change in patient reported outcomes
Time Frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
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)
Time Frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Percentage of patients who demonstrate a reduction in home systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg
Time Frame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
[at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
Percentage of patients who demonstrate a reduction in office systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg
Time Frame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
[at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
Change in home and office heart rate
Time Frame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
[at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ReCor Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN 0984

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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