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RADIANCE II

University of North Carolina at Chapel Hill


Description

The purpose of this study is to evaluate the safety and effectiveness of renal denervation (an experimental procedure that decreases nervous system activity involved in the control of blood pressure) using Recor Medical's Paradise Renal Denervation System in patients with Stage 2 hypertension on up to two medications.


Keywords:

Heart/Vascular, High Blood Pressure


Category:

Device

Qualifications

 


Age
18 - 75 years


Gender
Any


Study Population

Adult patients between the ages of 18 and 75 with Stage 2 hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure > 90 mmHg) who are on no more than two antihypertensive medications. Patients must have a history of receiving treatment with antihypertensive medications if not on medications at the time of consent.


Investigator

Rick Stouffer
Ernest and Hazel Craige Dist Prof
Medicine - Cardiology

For questions, contact:

Tyrone Wade
tyrone_wade@med.unc.edu
(919) 962-4896


Recruitment Period End

October 31, 2020

Location

Primary Location
Clinical & Translational Research Center
Burnett-Womack Building, 160 Dental Cir, Chapel Hill, NC 27514, USA
Secondary Location
UNC Hospitals Cardiac Catheterization Laboratory
101 Manning Dr, Chapel Hill, NC 27514, USA

Study Qualifications

Gender Any

Age Range 18 - 75 years

Participant qualification(s) 1. Documented history of high blood pressure 2. Previously or currently prescribed high blood pressure medication (if currently prescribed, no more than two can be prescribed) 3. Have Stage 2 hypertension (systolic blood pressure ≥140 mmHg AND diastolic blood pressure ≥90 mmHg)

Not eligible if: 1. Type I diabetes or uncontrolled Type II diabetes (HbA1c ≥9.0%) 2. Any history of stroke, transient ischemic attack or other cerebrovascular event 3. Any history of heart attack, open heart surgery, acute heart failure hospitalization 4. Active, implanted medical device (pacemaker, ICD, spinal simulators, etc.)

Number of Visits

    » 13 In person visit(s)

    12 clinic visits (which may include a CT scan or MRI scan), 1 overnight hospital stay

    » 0 Remote visit(s)

Participation Period

3 years

Compensation

$40 per completed clinic visit

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.