Actively Recruiting
The "Global Paradise System" Registry
Led by ReCor Medical, Inc. · Updated on 2023-07-07
3000
Participants Needed
35
Research Sites
519 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The "Global Paradise System" Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent
- Age 18 years or older at time of consent
- Patient is a candidate for renal denervation with the Paradise System based on physician's assessment OR treated with the Paradise System within 6 months prior to consent
You will not qualify if you...
- Any contraindication listed in the Instructions for Use
- Stented renal artery
- Under 18 years of age
- Pregnant
- Known allergy to contrast medium
- Renal artery diameter less than 3 mm or greater than 8 mm
- Presence of Fibromuscular Dysplasia (FMD) in the renal artery
- Renal artery aneurysm
- Renal artery stenosis greater than 30% of any origin
- Iliac or femoral artery stenosis that prevents insertion of the Paradise catheter
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
OLV Ziekenhuis Aalst
Aalst, Belgium
Not Yet Recruiting
2
CHU Saint Pierre Brussels
Brussels, Belgium
Not Yet Recruiting
3
UCL St Luc
Brussels, Belgium
Not Yet Recruiting
4
CHU Bordeaux Hôpital St. André
Bordeaux, France
Not Yet Recruiting
5
HEGP (Hôpital Européen Georges Pompidouv) Paris
Paris, France
Active, Not Recruiting
6
Centre Hospitalier de Pau
Pau, France
Not Yet Recruiting
7
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
Actively Recruiting
8
Charité Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin, Germany
Not Yet Recruiting
9
Klinikum Coburg GmbH
Coburg, Germany
Not Yet Recruiting
10
Universitätsklinikum Köln
Cologne, Germany
Not Yet Recruiting
11
Klinikum Lippe GmbH Detmold
Detmold, Germany
Not Yet Recruiting
12
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Germany
Not Yet Recruiting
13
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Not Yet Recruiting
14
Universitätsklinikum Erlangen
Erlangen, Germany
Active, Not Recruiting
15
Cardiovasculäres Centrum (CVC) Frankfurt
Frankfurt, Germany
Active, Not Recruiting
16
St. Barbara-Klinik Hamm Heessen
Hamm, Germany
Active, Not Recruiting
17
University Clinic of Saarland - Homburg
Homburg, Germany, D-66421
Actively Recruiting
18
Herzzentrum Leipzig GmbH
Leipzig, Germany, D-04289
Actively Recruiting
19
Sana Kliniken Lübeck gGmbH
Lübeck, Germany
Actively Recruiting
20
Marienhaus Klinikum Mainz
Mainz, Germany
Actively Recruiting
21
Detusches Herzzentrum München (DHM)
München, Germany
Actively Recruiting
22
Robert-Bosch-Krankenhaus GmbH Stuttgart
Stuttgart, Germany
Not Yet Recruiting
23
Schwarzwald-Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany
Not Yet Recruiting
24
Centre Hospitalier Princesse Grace Monaco
Monaco, Monaco
Not Yet Recruiting
25
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Not Yet Recruiting
26
Erasmus MC Rotterdam
Rotterdam, Netherlands
Not Yet Recruiting
27
HUG Geneve Switzerland
Geneva, Switzerland
Actively Recruiting
28
Heart Center Lucerne -Luzerner Kantonsspital
Lucerne, Switzerland
Not Yet Recruiting
29
Royal Bournemouth Hospital, Bournemoth
Bournemouth, United Kingdom
Not Yet Recruiting
30
Kent and Canterbury Hospital, Canterbury
Canterbury, United Kingdom
Not Yet Recruiting
31
University Hospital Wales, Cardiff
Cardiff, United Kingdom
Not Yet Recruiting
32
Queen Elizabeth Hospital, Glasgow
Glasgow, United Kingdom
Not Yet Recruiting
33
Hammersmith Hospital (Imperial College Healthcare NHS Trust)
London, United Kingdom
Not Yet Recruiting
34
WHRC - Barts Health, London
London, United Kingdom
Not Yet Recruiting
35
Freeman Hospital, Newcastle
Newcastle, United Kingdom
Not Yet Recruiting
Research Team
H
Helen Reeve-Stoffer, PhD
CONTACT
L
Lea Doyle
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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