| NCT ID | NCT05027685 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ReCor Medical, Inc. |
| Condition | Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2022-01-13 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2022-01-13 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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 Criteria: 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
Contact & Investigator
Sofie Brouwers, Prof.
PRINCIPAL INVESTIGATOR
OLV Ziekenhuis Aalst Belgium
Frequently Asked Questions
Who can join the NCT05027685 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05027685 currently recruiting?
Yes, NCT05027685 is actively recruiting participants. Contact the research team at hreeve-stoffer@recormedical.com for enrollment information.
Where is the NCT05027685 trial being conducted?
This trial is being conducted at Vienna, Austria, Wels, Austria, Aalst, Belgium, Brussels, Belgium and 11 additional locations.
Who is sponsoring the NCT05027685 clinical trial?
NCT05027685 is sponsored by ReCor Medical, Inc.. The principal investigator is Sofie Brouwers, Prof. at OLV Ziekenhuis Aalst Belgium. The trial plans to enroll 3,000 participants.