RECRUITINGOBSERVATIONAL

The "Global Paradise System" Registry

The "Global Paradise® System" Registry

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Appropriately signed and dated willing to sign a consent form - 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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.

Locations (20)

OLV Ziekenhuis Aalst

Aalst, Belgium

CHU Saint Pierre Brussels

Brussels, Belgium

UCL St Luc

Brussels, Belgium

CHU Bordeaux Hôpital St. André

Bordeaux, France

HEGP (Hôpital Européen Georges Pompidouv) Paris

Paris, France

Centre Hospitalier de Pau

Pau, France

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, Germany

Charité Universitätsmedizin Berlin Campus Benjamin Franklin

Berlin, Germany

Klinikum Coburg GmbH

Coburg, Germany

Universitätsklinikum Köln

Cologne, Germany

Klinikum Lippe GmbH Detmold

Detmold, Germany

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Cardiovasculäres Centrum (CVC) Frankfurt

Frankfurt, Germany

St. Barbara-Klinik Hamm Heessen

Hamm, Germany

University Clinic of Saarland - Homburg

Homburg, Germany

Herzzentrum Leipzig GmbH

Leipzig, Germany

Sana Kliniken Lübeck gGmbH

Lübeck, Germany

Marienhaus Klinikum Mainz

Mainz, Germany