The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves Trial II
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1 Department of Medicine Director, Transcatheter Aortic Valve Program June 2013 [First Name] [Last Name], [Suffix] [Hospital or Practice Name] [Address] [City], [State] [Zip] Dear Dr. [Last name], We are pleased to inform you that UW Hospital and Clinics is now participating in The PARTNER II Trial, studying transcatheter aortic valve replacement: The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves Trial II This trial is randomizing patients diagnosed with severe, symptomatic calcific native aortic stenosis who are at intermediate or high risk for surgery (STS 4) to either transcatheter aortic valve replacement (TAVR) with the new lower profile Edwards SAPIEN XT transcatheter heart valve or traditional surgical aortic valve replacement (AVR). Patients who enroll in The PARTNER II Trial may be randomized to either surgical AVR or TAVR. For patients who are randomized to TAVR, the balloon-expandable Edwards SAPIEN XT transcatheter aortic heart valve is delivered via a catheter-based approach, typically without the use of cardiopulmonary bypass. The PARTNER II Trial uses a multi-disciplinary approach to patient care. Our team includes cardiothoracic surgeons, interventional cardiologists, echocardiographers, anesthesiologists and preand post-operative care providers who ensure appropriate patient selection and maximize outcomes. In addition, study follow-up is for five years after AVR or TAVR. It is our hope that as you see patients in your daily practice at intermediate risk for surgical aortic valve replacement, you consider referring them for further evaluation as they may be candidates for this trial. We are willing to evaluate these patients either within the Valve Clinic at UW Hospital and Clinics or in our general clinics. If you would like additional information regarding this trial, or would like to refer a patient to the study, please contact our clinical research coordinator Soni Vander Ark, RN, MS at (608) or cav@medicine.wisc.edu or Ashley Harris at (608) or amharris@clinicaltrials.wisc.edu. Sincerely, Associate Professor of Medicine The UW PARTNER II Trial Team: Giorgio Gimelli, MD, Principal Investigator Lucian Lozonschi, MD, Co Investigator 600 Highland Avenue, MC 3248, Madison, WI Office: Fax:
2 Department of Medicine Director, Transcatheter Aortic Valve Program The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves Trial II We are pleased to inform you that UW Hospital and Clinics is now participating in The PARTNER II Trial, studying transcatheter aortic valve replacement. This trial is randomizing patients diagnosed with severe, symptomatic calcific native aortic stenosis who are at intermediate or high risk for surgery (STS 4) to either transcatheter aortic valve replacement (TAVR) with the new lower profile Edwards SAPIEN XT transcatheter heart valve or traditional surgical aortic valve replacement (AVR). Patients who enroll in The PARTNER II Trial may be randomized to either surgical AVR or TAVR. For patients who are randomized to TAVR, the balloon-expandable Edwards SAPIEN XT transcatheter aortic heart valve is delivered via a catheter-based approach, typically without the use of cardiopulmonary bypass. The PARTNER II Trial uses a multi-disciplinary approach to patient care. Our team includes cardiothoracic surgeons, interventional cardiologists, echocardiographers, anesthesiologists and preand post-operative care providers who ensure appropriate patient selection and maximize outcomes. In addition, study follow-up is for five years after AVR or TAVR. It is our hope that as you see patients in your daily practice at intermediate risk for surgical aortic valve replacement, you consider referring them for further evaluation as they may be candidates for this trial. We are willing to evaluate these patients either within the Valve Clinic at UW Hospital and Clinics or in our general clinics. If you would like additional information regarding this trial, or would like to refer a patient to the study, please contact our clinical research coordinator Soni Vander Ark, RN, MS at (608) or cav@medicine.wisc.edu or Ashley Harris at (608) or amharris@clinicaltrials.wisc.edu. Sincerely, Associate Professor of Medicine The UW PARTNER II Trial Team: Giorgio Gimelli, MD, Principal Investigator Lucian Lozonschi, MD, Co Investigator 600 Highland Avenue, MC 3248, Madison, WI Office: Fax:
3 The PARTNER II Trial To refer a patient, contact one of our clinical research coordinators: Ashley Harris (608) or amharris@clinicaltrials.wisc.edu Soni Vander Ark, RN, MS (608) or cav@medicine.wisc.edu
4 The UW PARTNER II Trial Team Giorgio Gimelli, MD Principal Investigator Lucian Lozonschi, MD Co-Investigator
5 600 Highland Ave., MC 3248 Madison, WI NonProfit US Postage PAID Permit No xxx Madison WI
Igor Palacios, MD Director of Interventional Cardiology Massachusetts General Hospital Professor of Medicine Harvard Medical School
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Policy Specific Section: March 30, 2012 March 7, 2013
Medical Policy Transcatheter Aortic Valve Replacement for Aortic Stenosis Type: Medical Necessity and Investigational / Experimental Policy Specific Section: Surgery Original Policy Date: Effective Date:
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