Global Paradise System US Post Approval Study

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.

Conditions

Hypertension, Cardiovascular Diseases, Vascular Diseases

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Study Overview

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Study Details

Study overview

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.

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

Global Paradise System US Post Approval Study

Condition
Hypertension
Intervention / Treatment

-

Contacts and Locations

Sacramento

Sutter Institute for Medical Research, Sacramento, California, United States, 95816

Bridgeport

Bridgeport Hosptial, Bridgeport, Connecticut, United States, 06610

Gainesville

The Cardiac & Vascular Institute, Gainesville, Florida, United States, 32605

Springfield

Southern Illinois University, Memorial Medical Center, Springfield, Illinois, United States, 62702

Boston

The Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Kansas City

Saint Luke's Mid America Heart Institute, Kansas City, Missouri, United States, 64111

Marlton

Virtua Health, Marlton, New Jersey, United States, 08053

New York

NYU Langone Health - Bellevue Hosptial, New York, New York, United States, 10016

New York

Columbia University Medical Center/New York Presbyterian Hospital, New York, New York, United States, 10032

Durham

Durham VA Health System, Durham, North Carolina, United States, 27705

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ReCor Medical, Inc.,

Study Record Dates

2031-07