Clinical trial NCT03434015 - References

Atrial Fibrillation — Post-approval Study of Percutaneous Left Atrial Appendage Closure ( FLAAC-2 )

Citation(s)

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  Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J. 2016 Aug;37(31):2465-74. doi: 10.1093/eurheartj/ehv730. Epub 2016 Jan 27.
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•   Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators
  Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X. Erratum in: Lancet. 2009 Nov 7;374(9701):1596.
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•   Kefer J, Vermeersch P, Budts W, Depotter T, Aminian A, Benit E, Stammen F
  Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac plug: the Belgian Registry. Acta Cardiol. 2013 Dec;68(6):551-8.
•   Klug D, Commeau P, Defaye P, Thambo JB, Gras D, Aubry P, Pasquie JL, Guerin P, Teiger E, Koning R, Piot O; Heart Rhythm, Pacing Group, the Atheroma, Interventional Cardiology Group of the French Society of Cardiology
  Percutaneous occlusion of the left atrial appendage: An expert consensus statement. Arch Cardiovasc Dis. 2015 Aug-Sep;108(8-9):460-7. Review.
•   Knecht S, Wilton SB, Haïssaguerre M
  The 2010 update of the ESC guidelines for the management of atrial fibrillation. Circ J. 2010 Nov;74(12):2534-7. Epub 2010 Nov 2. Review.
•   Lam YY, Yip GW, Yu CM, Chan WW, Cheng BC, Yan BP, Clugston R, Yong G, Gattorna T, Paul V
  Left atrial appendage closure with AMPLATZER cardiac plug for stroke prevention in atrial fibrillation: initial Asia-Pacific experience. Catheter Cardiovasc Interv. 2012 Apr 1;79(5):794-800. doi: 10.1002/ccd.23136. Epub 2011 Nov 30.
•   Menke J, Lüthje L, Kastrup A, Larsen J
  Thromboembolism in atrial fibrillation. Am J Cardiol. 2010 Feb 15;105(4):502-10. doi: 10.1016/j.amjcard.2009.10.018. Review.
•   Park JW, Bethencourt A, Sievert H, Santoro G, Meier B, Walsh K, Lopez-Minguez JR, Meerkin D, Valdés M, Ormerod O, Leithäuser B
  Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience. Catheter Cardiovasc Interv. 2011 Apr 1;77(5):700-6. doi: 10.1002/ccd.22764. Epub 2011 Mar 8. Erratum in: Catheter Cardiovasc Interv. 2014 Nov 15;84(6):1028. Lopez-Minquez, Jose Ramon [corrected to Lopez-Minguez, Jose Ramon].
•   Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S
  Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011 Feb 1;123(4):417-24. doi: 10.1161/CIRCULATIONAHA.110.976449. Epub 2011 Jan 17.
•   Reddy VY, Möbius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H
  Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10.
•   Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators
  Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. Erratum in: JAMA. 2015 Mar 10;313(10):1061.
•   Sick PB, Schuler G, Hauptmann KE, Grube E, Yakubov S, Turi ZG, Mishkel G, Almany S, Holmes DR
  Initial worldwide experience with the WATCHMAN left atrial appendage system for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2007 Apr 3;49(13):1490-5. Epub 2007 Mar 21.
•   Sievert H, Lesh MD, Trepels T, Omran H, Bartorelli A, Della Bella P, Nakai T, Reisman M, DiMario C, Block P, Kramer P, Fleschenberg D, Krumsdorf U, Scherer D
  Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience. Circulation. 2002 Apr 23;105(16):1887-9.

Post-approval Study of Percutaneous Left Atrial Appendage Closure

Details for clinical trial NCT03434015