The "Global Paradise System" Registry

NCT05027685 | Recruiting

• 1 other identifier: CLN-0927
• Study Type: observational
• Target: 3,000
• Locations: 7 countries
• Sites: 35

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.

Conditions

Hypertension

Keywords

Hypertension; Blood pressure; Renal Denervation

Outcome Measures

Primary Outcomes (23)

• Incidence of all-cause mortality

  Rate of mortality attributed to any causality as per site standard practice.

  Through 5 Years post-procedure

• Incidence of new onset end-stage renal disease

  eGFR\<15 mL/min/m2 or need for renal replacement therapy as per site standard practice

  Through 5 Years post-procedure

• Significant decline in renal function

  ≥50% increase in serum creatinine (mg/dL)

  Through 5 Years post-procedure

• New renal artery stenosis

  \>70% confirmed by CTA/MRA as per site standard practice.

  Through 5 Years post-procedure

• Incidence of renal artery perforation or dissection requiring an invasive intervention

  Through 5 Years post-procedure

• Incidence of major vascular complications (e.g, clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion as per site standard practice

  Through 5 Years post-procedure

• Incidence of hospitalization for hypertensive crisis or symptomatic hypotension

  Through 5 Years post-procedure

• Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF)

  Through 5 Years post-procedure

• Incidence of new onset stroke, TIA or CVA

  Through 5 Years post-procedure

• Incidence of acute myocardial infarction

  Through 5 Years post-procedure

• Incidence of any coronary revascularization

  Through 5 Years post-procedure

• Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment

  Through 5 Years post-procedure

• Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment

  Through 5 Years post-procedure

• Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment

  Through 5 Years post-procedure

• Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg

  Through 5 Years post-procedure

• Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg

  Through 5 Years post-procedure

• Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg

  Through 5 Years post-procedure

• Percentage of subjects who are controlled according to current guidelines

  Through 5 Years post-procedure

• Change in office/home/ambulatory pulse pressure in mmHg

  Through 5 Years post-procedure

• Change in office/home/ambulatory heart rate in bpm

  Through 5 Years post-procedure

• Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications

  Through 5 Years post-procedure

• Analysis of quarterly Home BP in mmHg

  Through 5 Years post-procedure

• Change from enrollment in quality of life scores as measured by the 12-item Short Form Health Survey (SF-12)

  The 12-item Short Form Health Survey (SF-12) is a measure of health-related quality-of-life. Scores for each domain range from 0 to 100, with a higher score indicating a more favorable health state.

  Through 5 Years post-procedure

Study Arms (1)

Renal Denervation Treatment

Patients candidate for treatment or already treated within 6 months prior to consent, as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System, will be enrolled in this single arm registry.

Device: The Paradise Ultrasound Renal Denervation System

Interventions

The Paradise Ultrasound Renal Denervation System DEVICE

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.

Renal Denervation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The GPS Registry will collect both retrospective and prospective data in patients treated as per the sites normal practice with the commercially available Paradise Ultrasound Renal Denervation System.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ReCor Medical, Inc.: lead

Study Sites (35)

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, D-66421, Germany

RECRUITING

Herzzentrum Leipzig GmbH

Leipzig, D-04289, 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

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Melvin Lobo, Prof.

  Barts NIHR Biomedical Research Centre, William Harvey Research Institute, QMUL

  PRINCIPAL INVESTIGATOR

• Felix Mahfoud, Prof.

  UKS Universitätsklinikum des Saarlandes, Kardiologie, Angiologie und internistische Intensivmedizin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Reeve-Stoffer, PhD

CONTACT

+44 (0) 794 774 8006; hreeve-stoffer@recormedical.com

Lea Doyle

CONTACT

+1 352 362 1021; Lea.Doyle@recormedical.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 30, 2021
• Study Start: January 13, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

DE (17); NL (2); FR (3); BE (3); CH (2); GB (7); MO (1)