Registry for the Paradise Ultrasound Renal Denervation System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The GPS Registry is an observational registry that collects data from patients treated with the Paradise Ultrasound Renal Denervation System. It aims to document the long-term safety and effectiveness of this treatment in patients deemed suitable for renal denervation based on physician assessment. The registry will gather telemetric Home Blood Pressure measurements and Patient Reported Outcome data through standardized quality of life questionnaires. This approach allows for comprehensive monitoring of patient outcomes in a real-world setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Klinikum Wels-Grieskirchen GmbH
  Wels, Austria Recruiting
• HEGP (Hôpital Européen Georges Pompidouv) Paris
  Paris, France Recruiting
• Universitäts-Herzzentrum Freiburg Bad Krozingen
  Bad Krozingen, Germany Recruiting
• Charité Universitätsmedizin Berlin Campus Benjamin Franklin
  Berlin, Germany Recruiting
• Universitätsklinikum Köln
  Cologne, Germany Recruiting
• Klinikum Lippe GmbH Detmold
  Detmold, Germany Recruiting

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Sofie Brouwers, Prof. — OLV Ziekenhuis Aalst Belgium
• Study coordinator: Helen Reeve-Stoffer, PhD
• Email: hreeve-stoffer@recormedical.com
• Phone: +44 (0) 794 774 8006

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using low-dose aspirin after preeclampsia to improve recovery

  This study is testing if taking low-dose aspirin for six months after having preeclampsia can help new moms recover better by improving their blood pressure and blood vessel function.

  Recruiting Phase 4 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT06281665

• IMB-guided health education to boost medication taking and blood pressure control in adults with hypertension

  This study tests a health-literacy program based on Information-Motivation-Behavioral Skills to help adults with hypertension who don’t take their medicines regularly to take them more consistently and better control their blood pressure.

  Recruiting at 8 sites Bahir Dar University · Ādēt and 7 other locations · NCT07894068

• Renal Nerve Stimulation to Help Blood Pressure in AF and HFpEF

  This study tests whether stimulating the kidneys with a catheter can safely lower blood pressure in adults with atrial fibrillation and HFpEF who also have hypertension.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT07893821

• Hypertension: Does Education Help Patients Manage Blood Pressure Better?

  This study tests whether structured patient education improves blood pressure control and self-management in adults with hypertension who speak Turkish.

  Recruiting Inonu University · Batman, Center · NCT07890090

• High BMI and periodontitis in Thai adults under 60

  This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.

  Recruiting Mahidol University · Bangkok, Ratchathewi · NCT07880717

• Long-term GW906 treatment for people with essential hypertension

  This trial tests whether long-term GW906 injections are safe and effective for adults with essential hypertension who completed an earlier GW906 study.

  Recruiting Shenzhen Salubris Pharmaceuticals Co., Ltd. · Shanghai, Shanghai Municipality · NCT07879755

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.