The "Global Paradise System" Registry
ConditionHypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorReCor Medical, Inc.
About this trial
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
Qualifiers
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
Disqualifiers
Stented renal artery
Less than 18 years of age
Pregnant
Known allergy to contrast medium
Trial design
Treatments tested in this trial
- The Paradise Ultrasound Renal Denervation System
Treatment groups
3,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov