As reported directly by the Minneapolis Heart Institute, this study represents a pivotal randomized blinded study of sponsor’s Recor’s Paradise® Ultrasound Denervation System for the treatment of high blood pressure. TrialSite News reviewed the study published in ClinicalTrials.gov to determine when the study was launched and how many research sites are participating. The study started in December 2018 and its targeted primary completion date is December 2020. The estimated study completion date is October 2024.
Minneapolis Heart Institute Foundation performance thus far: Good. Sponsor Recor has included 14 major research centers (sites) to recruit up to 225 participants.
The study centers on high blood pressure—impacting more than 1 billion people worldwide. According to the sponsor, 1 in 3 people struggle to get control of their high blood pressure-even when on medication. Medications are no longer effective for a growing number of patients, hence why the sponsor is evaluating the safety and effectiveness of an investigational device that focuses on the nerves around the renal (kidney) arteries that may be overactive in patients with high blood pressure. This investigators in in this study utilize a minimally invasive procedure to place a small, flexible catheter into the renal arteries leading to the kidneys and thereafter deliver ultrasound energy to the tissues around the renal arteries to decrease over-activity of the nerves.
Cardiologist Dr. Yale Wang is the lead investigator representing the Minneapolis Heart Institute. They are one of the leading institutions in the world studying this system. Previously, they acquired 66 consents and performed 14 randomizations in the ongoing RADIANCE-HTN SOLO study, which completed randomization at the end of 2017. Results of this past study presented in May 2018 at EuroPCR 2018 was also published in The Lancet. The primary endpoint was met.
The Minneapolis Heart Foundation was founded in 1982 when dedicated cardiovascular specialists from Minneapolis Heart Institute at Abbott Northwestern Hospital formed the Minneapolis Heart Institute Foundation (MHIF) to promote clinical research and education. Seeking an independent nonprofit research laboratory, the founding physicians sought to investigate and develop better ways to prevent, detect and treat heart and vascular disease. They pushed the boundaries beyond the status quo of current practice—all in the pursuit of seeking to improve lives and advance the field of cardiology.
Currently they are running at least 43 prominent clinical trials. They enroll nearly 1,000 cardiovascular-focused patients every year. Their team has conducted hundreds of studies covering a wide spectrum of disease prevention and cardiovascular care. They are enabled by the following:
- The Minneapolis Heart Institute at Abbott Northwestern practice
- Institutional review boards
- Access to complex data via national registries and databases
They recently led a research study reviewing FDA adverse event reports involving implantable cardioverter defibrillator (ICD) and found that some leads were much more likely than those made by Boston Scientific or Medtronic to fail due to internal insulation breaches (IBR). The team from MHIF reviewed the FDA MAUDE data from 2008 to 2018 for IBR breaches and other ICD failures. The MHIF team found that insulation breaches led to 93% of Abbott’s (formerly St. Jude Medical’s) Durata pacemaker lead failures. Lead Research/Investigator
Yale Wang, MD.Source: mplsheart.org