The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (P3) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Additionally, 30-day outcomes were also evaluated. Review. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined). Choosing to participate in a study is an important personal decision. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Device Product Not Approved or Cleared by U.S. FDA: Safety and Effectiveness - composite endpoint of all-cause mortality and stroke [ Time Frame: 1 Year ], New York Heart Association (NYHA) Functional Class [ Time Frame: 30 Days ]. 2018. 76. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Talk with your doctor and family members or friends about deciding to join a study. Information provided by (Responsible Party): To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR). (Clinical Trial), PARTNER 3 Trial - Mitral Valve in Valve is a Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve, Experimental: Failing mitral transcatheter valve, 19 Years and older (Adult, Older Adult), Contact: Elizabeth Charles 404-686-1249, Contact: Bluhm Cardiovascular Institute Clinical Trials Unit 312-926-4000, Northshore University Health System Research Institution, Contact: Justin Levisay, MD 847-570-2250, Boston, Massachusetts, United States, 02115, Rochester, Minnesota, United States, 55905, Barnes-Jewish Hospital/ Washington University, Saint Louis, Missouri, United States, 63110, Contact: Alan Zajarias, MD 855-825-8457, Morristown Medical Center/ Atlantic Health System Hospital, Morristown, New Jersey, United States, 07962, Columbia University Medical Center/ New York Presbyterian Hospital, The University of Texas Health Sciences Center at Houston, Bedford Park, South Australia, Australia, 5042, Northwestern University Feinberg School of Medicine. N Engl J Med. Voir la distance Distance. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: All-cause mortality, all stroke, and re-hospitalization [ Time Frame: 1 year post procedure ], Length of index hospitalization (Device and Control group) [ Time Frame: Number of days from index procedure to discharge (expected average of 7 days) ]. Current clinical practice has restricted the use of TAVR in patients who are at low risk and in younger patients, for whom surgery is standard therapy.” – Dr. M.J. Mack, M.D. Patients with clinical frailty, bicuspid aortic valves or other features that increased the risk of complications associated with TAVR were excluded. Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency. Of those 950 patients, 1-year data was available in 98.4% of patients. When discussing the results of the study, Dr. Mack discussed the currently restricted indication for TAVR. NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. PEUGEOT PARTNER 3 FOURGON III 1.6 BLUEHDI 100 S&S STANDARD 1000KG PREMIUM. Garantie 12 mois . Study record managers: refer to the Data Element Definitions if submitting registration or results information. SAVR with a commercially available bioprosthetic valve. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization. Keywords provided by Edwards Lifesciences: Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX. The 2019 PARTNER 3 trial randomized 1000 patients with symptomatic severe AS to TAVR versus SAVR and assessed for a primary outcome of death, nonfatal myocardial infarction, or rehospitalization. Please remove one or more studies before adding more. The average age of those treated was 73.4 years, and nearly 70% of patients were men. However, transvalvular aortic-valve gradients were better in the surgical arm. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193801. However, soon after the Reuters and New York Times released the conclusions of PARTNER 3 TRIAL, the New England Journal of Medicine published the entire trial unleashing disappointment and discussion one day before the trial was due to be presented at ACC19. Previously randomized trials showed that TAVR with both balloon expandable valves and self-expanding valves was either superior or non-inferior to surgery in patients with either a moderate or high risk of death with surgery.
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