Enrollment Completed in SOLO Cohort of ReCor's RADIANCE-HTN Study
January 5, 2018—ReCor Medical announced completion of enrollment in the SOLO cohort of its RADIANCE-HTN study. RADIANCE-HTN, which is evaluating ReCor's Paradise renal denervation system in patients with hypertension, involves two study cohorts: SOLO, whose patients are removed from antihypertensive medication and TRIO, whose patients are put on standardized medication. Both cohorts are randomized, blinded, sham-controlled, and powered independently for efficacy.
The Paradise device is an ultrasound-based system for intravascular denervation of the renal nerves. The company is conducting the RADIANCE-HTN clinical trial under an investigational device exemption from the US Food and Drug Administration in the United States and Europe. The Paradise system has European CE Mark approval, but is not approved for sale in the United States, advised ReCor.
According to the company, RADIANCE-HTN has enrolled 1,000 patients (165 in 2017) at 40 study centers in the United States, France, Belgium, the Netherlands, Germany, and the United Kingdom. The final patient of the 146 enrolled in the SOLO cohort was randomized at Massachusetts General Hospital, under the lead of Interventional Cardiologist Joseph Garasic, MD, and Randall Zusman, MD, Director of the MGH Hypertension Clinic.
Melvin Lobo, MD, Director of Barts Blood Pressure Center of Excellence at St Bartholomew's Hospital, London, United Kingdom, is one of the lead enrollers in the SOLO cohort. Dr. Lobo commented in the company's announcement, "Leaders in the hypertension field understand that patients struggle to persevere with multidrug regimens required to attain and maintain target blood pressure levels over their lifetimes. The completion of enrollment into the SOLO arm of RADIANCE-HTN is highly significant as this cohort represents the vast majority of hypertensive patients. If SOLO proves positive, then there may be a pathway, with additional study, to a reduction of medications, increased longer-term therapeutic options, and improved blood pressure control for our patients."
The study's Co-Principal Investigator, Laura Mauri, MD, of Brigham & Women's Hospital in Boston, Massachusetts, stated, "The 40 RADIANCE-HTN study centers have reached major milestones in 2017: completion of the SOLO cohort of the study, enrollment of 1,000 patients, and randomization of 165 study subjects in 1 year. These are significant achievements, and testimony to the interest of hypertensive patients in new therapeutic options. The Paradise technology is unique in its circumferential ablation profile, the procedure is straightforward, and we look forward to understanding its performance in the SOLO group later this year."