RECRUITING

Global Paradise System US Post Approval Study

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Conditions

HypertensionCardiovascular DiseasesVascular DiseasesBlood PressureUncontrolled HypertensionEssential HypertensionResistant HypertensionRenal DenervationUltrasound Renal Denervation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-28
Study Completion:2031-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06297291

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed and dated study informed consent
  2. * Documented history of hypertension
  3. * Documented history of prior or current antihypertensive medication(s)
  4. * Mean seated office systolic BP at screening ≥ 140 mmHg
  5. * Mean pre-procedure home systolic BP of ≥ 135 mmHg
  6. * Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2
  1. * Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter
  2. * Patient under the age of 18 years old at the time of consent
  3. * Patient is pregnant
  4. * Patients with transplanted kidney
  5. * Presence of abnormal kidney (or secreting adrenal) tumors
  6. * Renal arteries with diameter \< 3mm and \> 8mm
  7. * Renal artery with fibromuscular dysplasia (FMD)
  8. * Stented renal artery
  9. * Renal artery aneurysm
  10. * Renal artery diameter stenosis \>30%
  11. * Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter

Contacts and Locations

Study Contact

Helen Reeve-Stoffer, PhD
CONTACT
+1 650-912-9032
hreeve-stoffer@recormedical.com
Liz Sheehan
CONTACT
Liz.Sheehan@recormedical.com

Study Locations (Sites)

Sutter Institute for Medical Research
Sacramento, California, 95816
United States
Bridgeport Hosptial
Bridgeport, Connecticut, 06610
United States
The Cardiac & Vascular Institute
Gainesville, Florida, 32605
United States
Southern Illinois University, Memorial Medical Center
Springfield, Illinois, 62702
United States
The Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, 64111
United States
Virtua Health
Marlton, New Jersey, 08053
United States
NYU Langone Health - Bellevue Hosptial
New York, New York, 10016
United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
United States
Durham VA Health System
Durham, North Carolina, 27705
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States
Ascension Saint Thomas
Nashville, Tennessee, 37205
United States
TCR Institute
Kingwood, Texas, 77339
United States
Inova Fairfax Hospital
Fairfax, Virginia, 22042
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-06-28
Study Completion Date2031-07

Study Record Updates

Study Start Date2024-06-28
Study Completion Date2031-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Hypertension
  • Cardiovascular Diseases
  • Vascular Diseases