Any additional therapies which are required to treat symptomatic or advancing disease subjects will be reviewed by a Central Review Committee for endpoint evaluation as long as the subject was treated >6months after randomization so that all subjects may remain on the trial for the entire 5 years of follow up. All Intervention and Control subjects will be followed with an abbreviated annual contact for an additional three (3) years, for a total of five (5) years. After the 24-month evaluation, all subjects will be unblinded. Subjects will be evaluated at one (1), six (6), twelve (12), eighteen (18) and twenty-four (24) months post-randomization, to assess long-term safety, and functional and clinical status. To access HealthPartners UnityPoint Health. Subjects randomized to the Control group will experience an index procedure similar to the Intervention group (without device placement) to ensure that they will not be able to deduce the group assignment based on the type of intervention or time associated with the procedure.Īfter the study subjects are discharged, the subjects' primary care specialists (cardiologist/heart failure physician) and clinical investigation site staff will coordinate follow-up evaluations. The counties in our service area for Illinois include: Fulton, Jo Daviess, Peoria, Rock. After the proximal anchor of the implant is locked in place, safety and efficacy will be reconfirmed prior to releasing the CARILLON implant from the delivery system. With the distal aspect of the device anchored, incremental tension will be applied to plicate the peri-annular tissue. Subjects randomized to the Intervention group will undergo the CARILLON implant procedure. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Intervention or Control). Currently Unitypoint Clinic Senior Health Methodist Atrium's 13 physicians cover 9 specialty areas of medicine. If the subject meets the anatomic requirements for device placement, the subject will be randomized. The cardiology, heart & vascular surgery rating is based on analysis of various data categories, including patient outcomes in medical and surgical treatment of cardiovascular disease, volume of. Unitypoint Clinic Senior Health Methodist Atrium is a Group Practice with 1 Location. On the day of the procedure, a coronary angiogram will be performed to evaluate the coronary artery anatomy and a venogram to assess the suitability of the coronary sinus/great cardiac vein (CS/GCV) for placement of the CARILLON implant. Study subjects who are eligible for this clinical study will undergo a transthoracic echocardiographic examination prior to randomization to evaluate the inclusion criteria associated with the severity of mitral regurgitation as well as a review by a Central Review Committee to determine appropriateness for the implant procedure. Subjects will be randomized into one of two study groups using a 1:1 (Intervention : Control) ratio. She accepted a position with Wellendorf ENT in Carroll, Iowa, in early 2014.The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMRĪ total of 352 subjects will be randomized at up to 75 investigational sites in the United States, Canada, Europe and Australia. After completing her education she accepted a position in dermatology at Unity Point in Fort Dodge, Iowa, where she received advanced training in the administration of Botox and Juvederm. She graduated with honors upon completion of her master's degree in March 2012. Hospital affiliations include UnityPoint Health Methodist Hospital. This provider currently accepts 46 insurance plans including Medicare and Medicaid. That year she also returned to Iowa and, while completing her advanced degree, was employed by Greene County Medical Center in Jefferson, Iowa. Lionel Malebranche, MD, is a Cardiovascular Disease specialist practicing in Peoria, IL with 20 years of experience. This hospital has been recognized for America’s 100 Best Hospitals for Coronary Intervention Award. She entered the Masters of Nursing program at the University of Cincinnati in March 2010. UnityPoint Health - Methodist Hospital is a medical facility located in Peoria, IL. Choose this visit type if you have 1 or 2 health concerns to talk to your provider about such as a sore throat, cough, headache, muscle pain, or urinary tract infection. Phone representatives are available from 8 a.m. She then began her nursing career in the Neonatal Intensive Care Unit at Minneapolis Children's Hospital. For questions about MyUnityPoint, please call us at (877) 224-4430. Paul, Minnesota, where she received her Bachelor of Science Degree in Nursing in 2007. Facility/Office: Buena Vista Regional Medical CenterĮducation: Diana studied nursing at the College of St.
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