The Global Paradise® System Registry

Status: Recruiting
Location: See all (35) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
OLV Ziekenhuis Aalst
NOT_YET_RECRUITING
Aalst
CHU Saint Pierre Brussels
NOT_YET_RECRUITING
Brussels
UCL St Luc
NOT_YET_RECRUITING
Brussels
France
CHU Bordeaux Hôpital St. André
NOT_YET_RECRUITING
Bordeaux
HEGP (Hôpital Européen Georges Pompidouv) Paris
ACTIVE_NOT_RECRUITING
Paris
Centre Hospitalier de Pau
NOT_YET_RECRUITING
Pau
Germany
Universitäts-Herzzentrum Freiburg Bad Krozingen
RECRUITING
Bad Krozingen
Charité Universitätsmedizin Berlin Campus Benjamin Franklin
NOT_YET_RECRUITING
Berlin
Klinikum Coburg GmbH
NOT_YET_RECRUITING
Coburg
Universitätsklinikum Köln
NOT_YET_RECRUITING
Cologne
Klinikum Lippe GmbH Detmold
NOT_YET_RECRUITING
Detmold
Herzzentrum Dresden GmbH Universitätsklinik
NOT_YET_RECRUITING
Dresden
Universitätsklinikum Düsseldorf
NOT_YET_RECRUITING
Düsseldorf
Universitätsklinikum Erlangen
ACTIVE_NOT_RECRUITING
Erlangen
Cardiovasculäres Centrum (CVC) Frankfurt
ACTIVE_NOT_RECRUITING
Frankfurt
St. Barbara-Klinik Hamm Heessen
ACTIVE_NOT_RECRUITING
Hamm
University Clinic of Saarland - Homburg
RECRUITING
Homburg
Herzzentrum Leipzig GmbH
RECRUITING
Leipzig
Sana Kliniken Lübeck gGmbH
RECRUITING
Lübeck
Marienhaus Klinikum Mainz
RECRUITING
Mainz
Detusches Herzzentrum München (DHM)
RECRUITING
München
Robert-Bosch-Krankenhaus GmbH Stuttgart
NOT_YET_RECRUITING
Stuttgart
Schwarzwald-Baar Klinikum Villingen-Schwenningen
NOT_YET_RECRUITING
Villingen-schwenningen
Monaco
Centre Hospitalier Princesse Grace Monaco
NOT_YET_RECRUITING
Monaco
Netherlands
Noordwest Ziekenhuisgroep
NOT_YET_RECRUITING
Alkmaar
Erasmus MC Rotterdam
NOT_YET_RECRUITING
Rotterdam
Switzerland
HUG Geneve Switzerland
RECRUITING
Geneva
Heart Center Lucerne -Luzerner Kantonsspital
NOT_YET_RECRUITING
Lucerne
United Kingdom
Royal Bournemouth Hospital, Bournemoth
NOT_YET_RECRUITING
Bournemouth
Kent and Canterbury Hospital, Canterbury
NOT_YET_RECRUITING
Canterbury
University Hospital Wales, Cardiff
NOT_YET_RECRUITING
Cardiff
Queen Elizabeth Hospital, Glasgow
NOT_YET_RECRUITING
Glasgow
Hammersmith Hospital (Imperial College Healthcare NHS Trust)
NOT_YET_RECRUITING
London
WHRC - Barts Health, London
NOT_YET_RECRUITING
London
Freeman Hospital, Newcastle
NOT_YET_RECRUITING
Newcastle
Contact Information
Primary
Helen Reeve-Stoffer, PhD
hreeve-stoffer@recormedical.com
+44 (0) 794 774 8006
Backup
Lea Doyle
Lea.Doyle@recormedical.com
+1 352 362 1021
Time Frame
Start Date: 2022-01-13
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 3000
Treatments
Renal Denervation Treatment
Patients candidate for treatment or already treated within 6 months prior to consent, as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System, will be enrolled in this single arm registry.
Related Therapeutic Areas
Sponsors
Leads: ReCor Medical, Inc.

This content was sourced from clinicaltrials.gov