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RecruitingNCT05027685

The "Global Paradise System" Registry

Trial Parameters

ConditionHypertension
SponsorReCor Medical, Inc.
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment3,000
SexALL
Min Age18 Years
Max AgeN/A
Start Date2022-01-13
Completion2030-12-31
Interventions
The Paradise Ultrasound Renal Denervation System

Eligibility Fast-Check

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Brief Summary

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 Criteria

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

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