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The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.
The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Transcatheter Aortic Valve Implantation (TAVI) Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Device | Implantation of the Acurate Neo Transcatheter Heart Valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device success of implantation | Proportion of patients with device success of implantation defined as:
| 7 days |
| Cardiovascular death | Cumulative incidence of a combination of all cause Cardiovascular death | 30 days post-index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of early safety | Proportion of patients with early safety defined by the Valve Academic Research Consortium-2 (VARC-2) as:
|
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severe aortic stenosis with indication of implantation of aortic valve prosthesis in which an Acurate Neo device is implanted according to the indications for use.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias I Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital Universitari Vall D'Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20961243 | Background | Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22. | |
| 21639811 |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 30 days |
| Assessment of time-related valve safety | Proportion of patients with structural valve deterioration as defined by:
| 30 days |
| Assesment of NYHA (New York Heart Association ) classification | Assesment of NYHA classification | 7 days, 30 days, 12 month |
| Assessment of mean aortic gradient post-implantation | Assessment of mean aortic gradient post-implantation | up to one year |
| Death during the hospitalization of the patient | Proportion of patients with death during the hospitalization designated by the VARC-2 criteria | date of procedure till date of estimated discharge, assessed up to two weeks |
| Barcelona |
| 08035 |
| Spain |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital Universitario Virgen de Las Nieves | Granada | 18014 | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico de San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario de La Paz | Madrid | 28046 | Spain |
| Hospital Universitari I Politècnic de La Fé | Valencia | 46026 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47003 | Spain |
| Background |
| Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5. |
| 25184874 | Background | Adams DH, Popma JJ, Reardon MJ. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 Sep 4;371(10):967-8. doi: 10.1056/NEJMc1408396. No abstract available. |
| 27040324 | Background | Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2. |
| 28304219 | Background | Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17. |
| 25787196 | Background | Thyregod HG, Steinbruchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrom T, Clemmensen P, Hansen PB, Andersen LW, Olsen PS, Sondergaard L. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol. 2015 May 26;65(20):2184-94. doi: 10.1016/j.jacc.2015.03.014. Epub 2015 Mar 15. |
| 28886619 | Background | Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available. |
| 12831818 | Background | Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x. |
| 29329825 | Background | Pesarini G, Lunardi M, Piccoli A, Gottin L, Prati D, Ferrero V, Scarsini R, Milano A, Forni A, Faggian G, Ribichini F. Effectiveness and Safety of Transcatheter Aortic Valve Implantation in Patients With Pure Aortic Regurgitation and Advanced Heart Failure. Am J Cardiol. 2018 Mar 1;121(5):642-648. doi: 10.1016/j.amjcard.2017.11.042. Epub 2017 Dec 11. |
| 38577931 | Derived | Tebar D, Carrillo X, Garcia Del Blanco B, Gomez-Hospital JA, Nombela L, Molina E, Galeote G, Vilalta V, Serra-Garcia V, Carol GM, Jimenez-Valero S, Fernandez-Nofrerias E, Calabuig-Goena A, Jurado-Roman A, Sanchez-Recalde A, Velasco MF, Bosca L, Moreno R. Experience with the ACURATE neo and neo2 transcatheter aortic valves in Spain. The PRECISA (PRospective Evaluation Complementing Investigation with ACURATE devices) registry. Catheter Cardiovasc Interv. 2024 May;103(6):1015-1022. doi: 10.1002/ccd.31032. Epub 2024 Apr 5. |
| D014694 |
| Ventricular Outflow Obstruction |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |