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
This trial does not accept healthy volunteersQualifiers
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 population
The GPS Registry will collect both retrospective and prospective data in patients treated as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
The Paradise Ultrasound Renal Denervation System
DeviceThe CE-marked and commercially available ReCor Medical Paradise Ultrasound Renal Denervation System (Paradise System) is a catheter-based device designed to use ultrasound energy to thermally ablate the nerves surrounding the renal artery and serving the kidney.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Renal Denervation Treatment1 intervention
Trial outcomes
Primary outcomes
1
Incidence of all-cause mortality
Rate of mortality attributed to any causality as per site standard practice.
Time frame
Through 5 Years post-procedure2
Incidence of new onset end-stage renal disease
eGFR\<15 mL/min/m2 or need for renal replacement therapy as per site standard practice
Time frame
Through 5 Years post-procedure3
Significant decline in renal function
≥50% increase in serum creatinine (mg/dL)
Time frame
Through 5 Years post-procedure4
New renal artery stenosis
\>70% confirmed by CTA/MRA as per site standard practice.
Time frame
Through 5 Years post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov