NCT02447081|CompletedResults
Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)
Amulet™PMS
Amplatzer™Amulet™ Observational Post-Market Study
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Amulet™PMS
Amplatzer™Amulet™ Observational Post-Market Study
Sponsor study identifier
observational
1,088
16 countries
51
Study Start
June 1, 2015
Actual (reported)Primary Completion
October 23, 2018
Actual (reported)Study Completion
October 23, 2018
Actual (reported)This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 23, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2015
Actual (reported)May 18, 2015
Actual (reported)June 1, 2015
Actual (reported)October 23, 2018
Actual (reported)October 23, 2018
Actual (reported)December 30, 2019
Actual (reported)Number of Participants With Acute Serious Adverse Events
Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure
0 to 7 days post procedure
Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure
Late adverse events were defined as those serious events with an onset date \> 7 days post-procedure
7 days through 2 years
Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death
Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years
Implant through 2 years
Number of Participants With Major Bleeding Events
Clinical events were adjudicated by the CEC as major bleeding events if they met the definition of Type 3 or greater on the Bleeding Academic Research Consortium (BARC) scale.
Implant through 2 years
Number of Participants With Technical Success
During implant procedure, approximately 30 to 60 minutes
Number of Participants With Procedural Success
During the implant procedure and hospital stay, approximately 1 or 2 days
Number of Participants With Oral Anti-coagulation Usage
At discharge, approximately 1 or 2 days after the procedure
Number of Participants With Oral Anti-coagulation Usage
At 1 to 3 months
Number of Participants With Oral Anti-coagulation Usage
At 6 months
All subjects who receive the Amulet device will be followed.
Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with non-valvular atrial fibrillation
Fiona Stanley Hospital
Murdoch, Western Australia, WA 6150, Australia
Universitaire Ziekenhuizen Gasthuisberg
Leuven, Belgium
Hospital Clinico San Borja Arriaran
Santiago, 83600160, Chile
Rigshospitalet
Copenhagen, 2100, Denmark
Helsinki University Central Hospital
Helsinki, Uusimaa, Finland
Turku University Hospital
Turku, Finland
Hopital Haut Leveque
Pessac, Aquitaine, 33600, France
De Caterina AR, Nielsen-Kudsk JE, Schmidt B, Mazzone P, Fischer S, Lund J, Montorfano M, Gage R, Lam SCC, Berti S. Gender difference in left atrial appendage occlusion outcomes: Results from the Amplatzer Amulet Observational Study. Int J Cardiol Heart Vasc. 2021 Jul 26;35:100848. doi: 10.1016/j.ijcha.2021.100848. eCollection 2021 Aug.
Piayda K, Hellhammer K, Nielsen-Kudsk JE, Schmidt B, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Della Bella P, Gage R, Zeus T. Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study. BMJ Open. 2021 Mar 24;11(3):e040455. doi: 10.1136/bmjopen-2020-040455.
David Hildick-Smith, MD
Brighton and Sussex University Hospitals
Claudio Tondo, MD PhD
University of Milan
1,088 participants (actual enrollment reported by the registry).
First Submitted
April 27, 2015
First Posted
May 18, 2015
Study Start
June 1, 2015
Actual (reported)Amulet™ ADVANCE LAA
Contact the study team to confirm eligibility.
CHU du Bocage
Dijon, Burgundy, 21034, France
CHRU Lille
Lille, North-Calais, 59037, France
CHU d'Amiens
Amiens, Picardy, 80054, France
Klinikum Coburg
Coburg, Bavaria, 96450, Germany
Internistische Klinik Dr. Müller, München-Thalkirchen
Munich, Bavaria, 81379, Germany
Universitaetsklinikum Ulm
Ulm, Bavaria, 89081, Germany
Zentrum fur Herzgesundheit/Kardiologie am Alice Hospital Darmstadt
Darmstadt, Hesse, 64287, Germany
CardioVaskuläres Centrum St. Katharinen
Frankfurt am Main, Hesse, 60389, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphal, 40225, Germany
Zentralklinik Bad Berka Gmbh
Bad Berka, Thuringia, 99437, Germany
Zentralklinik Bad Berka
Bad Berka, Germany
Segeberger Kliniken Gmbh
Bad Segeberg, 23795, Germany
Segeberger Kliniken GmbH
Bad Segeberg, Germany
Charité - Universitätsmedizin Berlin (CBF)
Berlin, 12203, Germany
St. Marien Hospital Bonn
Bonn, 53115, Germany
Herzzentrum Dresden
Dresden, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, 60431, Germany
Klinikum Frankfurt Höchst
Frankfurt, 65929, Germany
Harzklinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, Germany
Rems-Murr-Klinikum Winnenden
Winnenden, 71364, Germany
Mater Hospital
Dublin, Ireland
The Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Nuovo Ospedale Civile Sant'Agostino Estense
Baggiovara, Modena, 41126, Italy
Ospedale dell'Angelo and Ospedale SS Giovanni e Paolo Venezia
Mestre, Veneto, 30174, Italy
Università degli Studi di Padova
Padova, Veneto, 35128, Italy
Azienda Ospedaliera S. Anna e S. Sebastiano
Caserta, 81100, Italy
Ospedale del Cuoro Fondazione C. N. R. Regione Toscana G. Monasterio
Massa, Italy
Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, Unveristiy of Milan
Milan, Italy
San Raffaele Hospital
Milan, Italy
Ospedale Luigi Sacco
Milan, 20157, Italy
Amsterdam Academic Medical Centre
Veenendaal, Netherlands
Ulleval Universitetssykehus
Oslo, 0407, Norway
Slaskie Centrum Chorob Serca
Warsaw, 01-785, Poland
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, 04-628, Poland
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41007, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Island, 07120, Spain
Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, Catalonia, 08025, Spain
Hospital Universitario Infanta Cristina
Badajoz, Extremadura, 6080, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, 8028, Spain
Karolinska University Hospital Huddinge
Stockholm, 17176, Sweden
Liverpool Heart and Chest Hospital
Liverpool, Northwest England, United Kingdom
The Royal Sussex Country Hospital
Brighton, South East England, United Kingdom
St Thomas Hospital
London, SE1 7EH, United Kingdom
Aminian A, De Backer O, Nielsen-Kudsk JE, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Lam SCC, Freixa X, Gage R, Diener HC, Schmidt B. Incidence and clinical impact of major bleeding following left atrial appendage occlusion: insights from the Amplatzer Amulet Observational Post-Market Study. EuroIntervention. 2021 Oct 20;17(9):774-782. doi: 10.4244/EIJ-D-20-01309.
Tarantini G, D'Amico G, Schmidt B, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Della Bella P, Lam SCC, Cruz-Gonzalez I, Gage R, Zhao H, Omran H, Odenstedt J, Nielsen-Kudsk JE. The Impact of CHA2DS2-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study. JACC Cardiovasc Interv. 2020 Sep 28;13(18):2099-2108. doi: 10.1016/j.jcin.2020.06.003.
Primary Completion
October 23, 2018
Actual (reported)Study Completion
October 23, 2018
Actual (reported)Last Updated
December 30, 2019
Results First Posted
December 30, 2019
Record last verified: 2019-12
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Source: ClinicalTrials.gov.
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