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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent

• Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen

Locations
United States
Florida
The Cardiac and Vascular Institute
Recruiting
Gainesville
Georgia
Emory
Recruiting
Atlanta
Illinois
Northwestern University
Recruiting
Chicago
SIU Medicine
Recruiting
Springfield
Louisiana
Ochsner Medical Center
Recruiting
New Orleans
Massachusetts
The Brigham and Women's Hospital
Recruiting
Boston
Missouri
Saint Luke's Hospital
Recruiting
Kansas City
New York
Columbia University Medical Center/NYPH
Recruiting
New York
Pennsylvania
Penn Medicine
Recruiting
Philadelphia
UPMC Heart and Vascular Center
Recruiting
Pittsburgh
South Carolina
Medical University of South Carolina
Recruiting
Charleston
Washington
Swedish Health Services
Recruiting
Seattle
Contact Information
Primary
Helen Reeve-Stoffer, PhD
hreeve-stoffer@recormedical.com
+44 7947 748006
Backup
Elizabeth Sheehan, MLIS
liz.sheehan@recormedical.com
Time Frame
Start Date: May 4, 2022
Estimated Completion Date: December 31, 2028
Participants
Target number of participants: 300
Treatments
Experimental: Renal Denervation
Related Therapeutic Areas
Sponsors
Leads: ReCor Medical, Inc.

This content was sourced from clinicaltrials.gov

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