Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
1088 participants
OBSERVATIONAL
2015-06-01
2018-10-23
Brief Summary
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Detailed Description
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The study assessed acute and late serious adverse events and reports the rate of stroke and bleeding events through 2 years. No formal hypothesis were tested for this observational post-market study.
Each patient was followed at study visits at baseline, implant, 1-3 months, 6 months, 12 months, and 24 months post implant."
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Subjects implanted with Amulet Device
All subjects who receive the Amulet device will be followed.
Subjects implanted with Amulet Device
Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Interventions
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Subjects implanted with Amulet Device
Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Eligibility Criteria
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Inclusion Criteria
2. Subject who is 18 years or older, or of legal age to give informed consent specific to state and national law
3. Subject who is eligible for an Amulet LAA Occluder device according to current international guidelines and per physician discretion
4. Subject who is willing and capable of providing informed consent, participating in all associated study activities
Exclusion Criteria
2. Subject with active infection or active endocarditis or other infections producing bacteremia
3. Subject where the placement of the device would interfere with any intracardiac or intravascular structures
4. Subject with any medical disorder that would interfere with completion or evaluation of clinical study results
5. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
6. Subject with LAA anatomy that does not accommodate a device per the sizing guidelines
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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David Hildick-Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Brighton and Sussex University Hospitals
Claudio Tondo, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Milan
Locations
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Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Universitaire Ziekenhuizen Gasthuisberg
Leuven, , Belgium
Hospital Clinico San Borja Arriaran
Santiago, , Chile
Rigshospitalet
Copenhagen, , Denmark
Helsinki University Central Hospital
Helsinki, Uusimaa, Finland
Turku University Hospital
Turku, , Finland
Hopital Haut Leveque
Pessac, Aquitaine, France
CHU du Bocage
Dijon, Burgundy, France
CHRU Lille
Lille, North-Calais, France
CHU d'Amiens
Amiens, Picardy, France
Klinikum Coburg
Coburg, Bavaria, Germany
Internistische Klinik Dr. Müller, München-Thalkirchen
Munich, Bavaria, Germany
Universitaetsklinikum Ulm
Ulm, Bavaria, Germany
Zentrum fur Herzgesundheit/Kardiologie am Alice Hospital Darmstadt
Darmstadt, Hesse, Germany
CardioVaskuläres Centrum St. Katharinen
Frankfurt am Main, Hesse, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphal, Germany
Zentralklinik Bad Berka Gmbh
Bad Berka, Thuringia, Germany
Zentralklinik Bad Berka
Bad Berka, , Germany
Segeberger Kliniken Gmbh
Bad Segeberg, , Germany
Segeberger Kliniken GmbH
Bad Segeberg, , Germany
Charité - Universitätsmedizin Berlin (CBF)
Berlin, , Germany
St. Marien Hospital Bonn
Bonn, , Germany
Herzzentrum Dresden
Dresden, , Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, , Germany
Klinikum Frankfurt Höchst
Frankfurt, , Germany
Harzklinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, , Germany
Rems-Murr-Klinikum Winnenden
Winnenden, , Germany
Mater Hospital
Dublin, , Ireland
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Nuovo Ospedale Civile Sant'Agostino Estense
Baggiovara, Modena, Italy
Ospedale dell'Angelo and Ospedale SS Giovanni e Paolo Venezia
Mestre, Veneto, Italy
Università degli Studi di Padova
Padua, Veneto, Italy
Azienda Ospedaliera S. Anna e S. Sebastiano
Caserta, , 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, , Italy
Amsterdam Academic Medical Centre
Veenendaal, , Netherlands
Ulleval Universitetssykehus
Oslo, , Norway
Slaskie Centrum Chorob Serca
Warsaw, , Poland
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, , Poland
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Island, Spain
Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, Catalonia, Spain
Hospital Universitario Infanta Cristina
Badajoz, Extremadura, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, , Spain
Karolinska University Hospital Huddinge
Stockholm, , 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, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SJM-CIP-10053
Identifier Type: -
Identifier Source: org_study_id