Insights From the Early Experience of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry |
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Affiliation: | 1. Denver VA Medical Center, Denver, Colorado;2. Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota;3. Campbell University College of Pharmacy and Health Sciences, Buies Creek, North Carolina;4. University of Florida Health Sciences Center, Jacksonville, Florida;6. Centers for Medicare and Medicaid Services, Baltimore, Maryland;5. Baylor Healthcare System, Heart Hospital Baylor, Dallas, Texas |
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Abstract: | The current system for postmarket surveillance of medical devices in the United States is limited. To help change this paradigm for transcatheter valve therapies (TVTs), starting with transcatheter aortic valve replacement, the Society of Thoracic Surgeons and the American College of Cardiology partnered to form the TVT Registry program in close collaboration with the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services. The goal of the TVT Registry is to measure and improve quality of care and patient outcomes in clinical practice and to have a pivotal role in the scientific evidence and surveillance for medical devices. Challenges were faced in the early experience of the registry included developing multistakeholder partnerships, data collection requirements, and the use of the registry for pre- and post-market device evaluations. In addressing these challenges, the TVT Registry demonstrates that it is feasible for professional societies to assume a pivotal role in pre- and/or post-market studies, leveraging a clinical registry infrastructure. Sharing the TVT Registry experience may help other professional societies and stakeholders better anticipate and plan for these challenges. |
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Keywords: | Centers for Medicare and Medicaid Services (U.S.) heart valve prosthesis implantation investigational device exemption National Cardiovascular Data Registry, registries transcatheter aortic valve replacement U.S. Food and Drug Administration ACC" },{" #name" :" keyword" ," $" :{" id" :" kwrd0050" }," $$" :[{" #name" :" text" ," _" :" American College of Cardiology CMS" },{" #name" :" keyword" ," $" :{" id" :" kwrd0060" }," $$" :[{" #name" :" text" ," _" :" Centers for Medicare and Medicaid Services FDA" },{" #name" :" keyword" ," $" :{" id" :" kwrd0070" }," $$" :[{" #name" :" text" ," _" :" U.S. Food and Drug Administration IDE" },{" #name" :" keyword" ," $" :{" id" :" kwrd0080" }," $$" :[{" #name" :" text" ," _" :" Investigational Device Exemption NCDR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0090" }," $$" :[{" #name" :" text" ," _" :" National Cardiovascular Data Registry PAS" },{" #name" :" keyword" ," $" :{" id" :" kwrd0100" }," $$" :[{" #name" :" text" ," _" :" post-approval study STS" },{" #name" :" keyword" ," $" :{" id" :" kwrd0110" }," $$" :[{" #name" :" text" ," _" :" Society of Thoracic Surgeons TAVR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0120" }," $$" :[{" #name" :" text" ," _" :" transcatheter aortic valve replacement TVT" },{" #name" :" keyword" ," $" :{" id" :" kwrd0130" }," $$" :[{" #name" :" text" ," _" :" transcatheter valve therapy |
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