The "Global Paradise System" Registry
The "Global Paradise® System" Registry
ReCor Medical, Inc.
3,000 participants
Jan 13, 2022
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
Inclusion Criteria3
- 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 Criteria11
- 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
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05027685