RADIANCE Continued Access Protocol (RADIANCE CAP) A study of the ReCor Medical Paradise System in Clinical Hypertension

  • Clinical Trial Information

    Trial Contact: Cox, Caitlin L; Hernandez-Pagan, Gloryvee; Ngo, George M.

  • IRB No: WIRB20215781

    Protocol Abbrev: RADIANCE-CAP

    Principal Investigator: Farhan Javed Khawaja, MD

    Phase: Device: Non-significant Risk

    Age Group: Adult

    Secondary Protocol No: CLN-0932

    Treatment: The system is a catheter-based device designed to use ultrasound energy to thermally ablate the afferent and efferent nerves surrounding the renal artery and serving the kidney.

    Therapies Involved: Procedural ID: NCT05017935

  • Objective

    To continue to collect safety and effectiveness data on the Paradise System in hypertensive subjects.

  • Key Eligibility

    1. Appropriately signed and dated informed consent
    2. Age ≥18 and ≤75 years at the time of consent
    3. Documented history of hypertension
    Average seated office BP ≥140/90 mmHg at Screening Visit (V0):
    Able and willing to comply with all study procedures