Recruiting

The "Global Paradise System" Registry

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…

ClinicalTrials.gov IDNCT05027685

PhaseNot Applicable

Enrollment3000

SponsorReCor Medical, Inc.

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Hypertension

About this study

Interventions

Device: The Paradise Ultrasound Renal Denervation System — The 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.

Primary outcomes

Incidence of all-cause mortality (Through 5 Years post-procedure)
Incidence of new onset end-stage renal disease (Through 5 Years post-procedure)
Significant decline in renal function (Through 5 Years post-procedure)
New renal artery stenosis (Through 5 Years post-procedure)
Incidence of renal artery perforation or dissection requiring an invasive intervention (Through 5 Years post-procedure)
Incidence of major vascular complications (e.g, clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion as per site standard practice (Through 5 Years post-procedure)
Incidence of hospitalization for hypertensive crisis or symptomatic hypotension (Through 5 Years post-procedure)
Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF) (Through 5 Years post-procedure)

Eligibility information

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 locations

Medical University of Vienna,, Vienna, 1090 Austria
Klinikum Wels-Grieskirchen GmbH, Wels, 4600 Austria
OLV Ziekenhuis Aalst, Aalst, Belgium
CHU Saint Pierre Brussels, Brussels, Belgium
UCL St Luc, Brussels, Belgium
Clinique CHS MontLégia, Liège, 4000 Belgium
CHU Grenoble Alpes - Hôpital Michallon, Grenoble, La Tronche 38700 France
CHU Bordeaux Hôpital St. André, Bordeaux, France
Assistance Publique Hôpitaux de Marseille (AP-HM), Marseille, 13354 France
HEGP (Hôpital Européen Georges Pompidouv) Paris, Paris, France

Showing 10 of 55 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-28.