The "Global Paradise System" Registry (GPS Registry)

ReCor Medical

Status: Enrolling

Conditions: Hypertension

Treatments: Device: The Paradise Ultrasound Renal Denervation System

Study type: Observational

Funder types: Industry

Identifiers

NCT05027685

CLN-0927

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

Renal Denervation Treatment

Description:

Patients candidate for treatment or already treated within 6 months prior to consent, as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System, will be enrolled in this single arm registry.

Treatment:

Device: The Paradise Ultrasound Renal Denervation System