Registry for the Paradise Ultrasound Renal Denervation System
The "Global Paradise® System" Registry
This study is tracking how well the Paradise Ultrasound Renal Denervation System works and its safety for patients with high blood pressure over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ReCor Medical, Inc. Industry-sponsored |
| Locations | 35 sites (Aalst and 34 other locations) |
| Trial ID | NCT05027685 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older who are assessed by their physician as suitable for renal denervation with the Paradise System.
Not a fit: Patients with contraindications such as stented renal arteries, certain artery conditions, or those under 18 years of age may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of renal denervation for managing hypertension.
How similar studies have performed: Other studies on renal denervation have shown promising results, indicating that this approach may be effective, although this specific registry is focused on observational data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalst and 34 other locations
- OLV Ziekenhuis Aalst — Aalst, Belgium (Not_yet_recruiting)
- CHU Saint Pierre Brussels — Brussels, Belgium (Not_yet_recruiting)
- UCL St Luc — Brussels, Belgium (Not_yet_recruiting)
- CHU Bordeaux Hôpital St. André — Bordeaux, France (Not_yet_recruiting)
- HEGP (Hôpital Européen Georges Pompidouv) Paris — Paris, France (Active_not_recruiting)
- Centre Hospitalier de Pau — Pau, France (Not_yet_recruiting)
- Universitäts-Herzzentrum Freiburg Bad Krozingen — Bad Krozingen, Germany (Recruiting)
- Charité Universitätsmedizin Berlin Campus Benjamin Franklin — Berlin, Germany (Not_yet_recruiting)
- Klinikum Coburg GmbH — Coburg, Germany (Not_yet_recruiting)
- Universitätsklinikum Köln — Cologne, Germany (Not_yet_recruiting)
- Klinikum Lippe GmbH Detmold — Detmold, Germany (Not_yet_recruiting)
- Herzzentrum Dresden GmbH Universitätsklinik — Dresden, Germany (Not_yet_recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Not_yet_recruiting)
- Universitätsklinikum Erlangen — Erlangen, Germany (Active_not_recruiting)
- Cardiovasculäres Centrum (CVC) Frankfurt — Frankfurt, Germany (Active_not_recruiting)
- St. Barbara-Klinik Hamm Heessen — Hamm, Germany (Active_not_recruiting)
- University Clinic of Saarland - Homburg — Homburg, Germany (Recruiting)
- Herzzentrum Leipzig GmbH — Leipzig, Germany (Recruiting)
- Sana Kliniken Lübeck gGmbH — Lübeck, Germany (Recruiting)
- Marienhaus Klinikum Mainz — Mainz, Germany (Recruiting)
- Detusches Herzzentrum München (DHM) — München, Germany (Recruiting)
- Robert-Bosch-Krankenhaus GmbH Stuttgart — Stuttgart, Germany (Not_yet_recruiting)
- Schwarzwald-Baar Klinikum Villingen-Schwenningen — Villingen-Schwenningen, Germany (Not_yet_recruiting)
- Centre Hospitalier Princesse Grace Monaco — Monaco, Monaco (Not_yet_recruiting)
- Noordwest Ziekenhuisgroep — Alkmaar, Netherlands (Not_yet_recruiting)
- Erasmus MC Rotterdam — Rotterdam, Netherlands (Not_yet_recruiting)
- HUG Geneve Switzerland — Geneva, Switzerland (Recruiting)
- Heart Center Lucerne -Luzerner Kantonsspital — Lucerne, Switzerland (Not_yet_recruiting)
- Royal Bournemouth Hospital, Bournemoth — Bournemouth, United Kingdom (Not_yet_recruiting)
- Kent and Canterbury Hospital, Canterbury — Canterbury, United Kingdom (Not_yet_recruiting)
- University Hospital Wales, Cardiff — Cardiff, United Kingdom (Not_yet_recruiting)
- Queen Elizabeth Hospital, Glasgow — Glasgow, United Kingdom (Not_yet_recruiting)
- Hammersmith Hospital (Imperial College Healthcare NHS Trust) — London, United Kingdom (Not_yet_recruiting)
- WHRC - Barts Health, London — London, United Kingdom (Not_yet_recruiting)
- Freeman Hospital, Newcastle — Newcastle, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Melvin Lobo, Prof. — Barts NIHR Biomedical Research Centre, William Harvey Research Institute, QMUL
- Study coordinator: Helen Reeve-Stoffer, PhD
- Email: hreeve-stoffer@recormedical.com
- Phone: +44 (0) 794 774 8006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.