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The "Global Paradise System" Registry

NCT05027685 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2023-07-07

No results posted yet for this study

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

Interventions

DEVICE

The Paradise Ultrasound Renal Denervation System

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.

Sponsors & Collaborators

  • ReCor Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Melvin Lobo, Prof. · Barts NIHR Biomedical Research Centre, William Harvey Research Institute, QMUL

  • Felix Mahfoud, Prof. · UKS Universitätsklinikum des Saarlandes, Kardiologie, Angiologie und internistische Intensivmedizin

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2030-12-31
Completion
2031-12-31

Countries

  • Belgium
  • France
  • Germany
  • Monaco
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05027685 on ClinicalTrials.gov