RecruitingNCT05027685

The "Global Paradise System" Registry

The "Global Paradise® System" Registry


Sponsor

ReCor Medical, Inc.

Enrollment

3,000 participants

Start Date

Jan 13, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a registry study — meaning it collects data rather than testing a new treatment — for patients who receive or have recently received a procedure called renal denervation using the "Paradise" ultrasound device. The device uses sound waves to disrupt overactive nerve signals in the kidney arteries that can raise blood pressure. **You may be eligible if...** - You are 18 or older - Your doctor has recommended renal denervation with the Paradise device, OR - You have already had the procedure within the past 6 months **You may NOT be eligible if...** - You have a stent in your kidney artery - You are pregnant - You are allergic to contrast dye - Your kidney arteries are too small, too large, or have disease (such as aneurysm or narrowing more than 30%) - You have blood vessel disease in the hip/groin that would prevent the catheter from being inserted Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEThe 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(35)

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

Detusches Herzzentrum München (DHM)

München, Germany

Robert-Bosch-Krankenhaus GmbH Stuttgart

Stuttgart, Germany

Schwarzwald-Baar Klinikum Villingen-Schwenningen

Villingen-Schwenningen, Germany

Centre Hospitalier Princesse Grace Monaco

Monaco, Monaco

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Erasmus MC Rotterdam

Rotterdam, Netherlands

HUG Geneve Switzerland

Geneva, Switzerland

Heart Center Lucerne -Luzerner Kantonsspital

Lucerne, Switzerland

Royal Bournemouth Hospital, Bournemoth

Bournemouth, United Kingdom

Kent and Canterbury Hospital, Canterbury

Canterbury, United Kingdom

University Hospital Wales, Cardiff

Cardiff, United Kingdom

Queen Elizabeth Hospital, Glasgow

Glasgow, United Kingdom

Hammersmith Hospital (Imperial College Healthcare NHS Trust)

London, United Kingdom

WHRC - Barts Health, London

London, United Kingdom

Freeman Hospital, Newcastle

Newcastle, United Kingdom

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NCT05027685


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