Status:
RECRUITING
The "Global Paradise System" Registry
Lead Sponsor:
ReCor Medical, Inc.
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT05027685
Start Date
January 13 2022
End Date
December 31 2031
Last Update
July 7 2023
Active Locations (35)
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1
OLV Ziekenhuis Aalst
Aalst, Belgium
2
CHU Saint Pierre Brussels
Brussels, Belgium
3
UCL St Luc
Brussels, Belgium
4
CHU Bordeaux Hôpital St. André
Bordeaux, France