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.
Trial Phone: 321-841-1505 ; 321-841-3686 ; 3218439657
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
ClinicalTrials.gov ID: NCT05017935
To continue to collect safety and effectiveness data on the Paradise System in hypertensive subjects.
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