Image

The "Global Paradise System" Registry

The "Global Paradise System" Registry

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.

Eligibility

Inclusion Criteria:

  • Appropriately signed and dated informed consent
  • Age ≥18 at time of consent
  • Patient candidate for renal denervation with the Paradise System based on physician's assessment OR Patient treated with the Paradise Ultrasound Renal Denervation System within the 6 months prior to consent

Exclusion Criteria:

        Patients who meet any of the contraindications listed in the Instructions for Use will be
        excluded.
        The contraindications are:
          -  Stented renal artery
          -  Less than 18 years of age
          -  Pregnant
          -  Known allergy to contrast medium
          -  Renal arteries diameter < 3 mm and > 8 mm
          -  Renal artery with Fibromuscular (FMD) disease
          -  Renal artery aneurysm
          -  Renal artery stenosis of any origin >30%
          -  Iliac/femoral artery stenosis precluding insertion of the Paradise catheter

Study details
    Hypertension

NCT05027685

ReCor Medical, Inc.

25 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.