Clinical trial NCT02447081: Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)
Official title: Amplatzer™Amulet™ Observational Post-Market Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Thromboembolism
Stroke
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-05-18
Enrollment: 1088
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-valvular atrial fibrillation

Brief summary: 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."

Detailed description: A total of 1088 subjects were enrolled in the study at 61 sites internationally, outside the United States.

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."

Eligibility criteria: Inclusion Criteria:

1. Subject with history of paroxysmal, persistent or permanent NVAF
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:

1. Subject with evidence of an intracardiac thrombus
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

Primary outcomes:
measure: Number of Participants With Acute Serious Adverse Events
timeFrame: 0 to 7 days post procedure
measure: Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure
timeFrame: 7 days through 2 years
measure: Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death
timeFrame: Implant through 2 years
measure: Number of Participants With Major Bleeding Events
timeFrame: Implant through 2 years
Secondary outcomes:
measure: Number of Participants With Technical Success
timeFrame: During implant procedure, approximately 30 to 60 minutes
measure: Number of Participants With Procedural Success
timeFrame: During the implant procedure and hospital stay, approximately 1 or 2 days
measure: Number of Participants With Oral Anti-coagulation Usage
timeFrame: At discharge, approximately 1 or 2 days after the procedure
measure: Number of Participants With Oral Anti-coagulation Usage
timeFrame: At 1 to 3 months
measure: Number of Participants With Oral Anti-coagulation Usage
timeFrame: At 6 months
measure: Number of Participants With Oral Anti-coagulation Usage
timeFrame: At 12 months
measure: Number of Participants With Oral Anti-coagulation Usage
timeFrame: At 24 months
Other outcomes:
Locations:
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Gasthuisberg
city: Santiago
country: Chile
facility: Hospital Clinico San Borja Arriaran
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital
city: Pessac
country: France
facility: Hopital Haut Leveque
state: Aquitaine
city: Dijon
country: France
facility: CHU du Bocage
state: Burgundy
city: Lille
country: France
facility: CHRU Lille
state: North-Calais
city: Amiens
country: France
facility: CHU d'Amiens
state: Picardy
city: Coburg
country: Germany
facility: Klinikum Coburg
state: Bavaria
city: Muenchen
country: Germany
facility: Internistische Klinik Dr. Müller, München-Thalkirchen
state: Bavaria
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
state: Bavaria
city: Darmstadt
country: Germany
facility: Zentrum fur Herzgesundheit/Kardiologie am Alice Hospital Darmstadt
state: Hesse
city: Frankfurt
country: Germany
facility: CardioVaskuläres Centrum St. Katharinen
state: Hesse
city: Duesseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
state: North Rhine-Westphal
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka Gmbh
state: Thuringia
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken Gmbh
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin (CBF)
city: Bonn
country: Germany
facility: St. Marien Hospital Bonn
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Höchst
city: Quedlinburg
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben GmbH
city: Winnenden
country: Germany
facility: Rems-Murr-Klinikum Winnenden
city: Dublin
country: Ireland
facility: Mater Hospital
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Baggiovara, 1355
country: Italy
facility: Nuovo Ospedale Civile Sant'Agostino Estense
state: Modena
city: Mestre
country: Italy
facility: Ospedale dell'Angelo and Ospedale SS Giovanni e Paolo Venezia
state: Veneto
city: Padova
country: Italy
facility: Università degli Studi di Padova
state: Veneto
city: Caserta
country: Italy
facility: Azienda Ospedaliera S. Anna e S. Sebastiano
city: Massa
country: Italy
facility: Ospedale del Cuoro Fondazione C. N. R. Regione Toscana G. Monasterio
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Milan
country: Italy
facility: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, Unveristiy of Milan
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Veenendaal
country: Netherlands
facility: Amsterdam Academic Medical Centre
city: Oslo
country: Norway
facility: Ulleval Universitetssykehus
city: Warsaw
country: Poland
facility: The Cardinal Stefan Wyszynski Institute of Cardiology
city: Warszawa
country: Poland
facility: Slaskie Centrum Chorob Serca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalusia
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Balearic Island
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Castile And Leon
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
state: Catalonia
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
state: Extremadura
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
state: Northwest England
city: Brighton
country: United Kingdom
facility: The Royal Sussex Country Hospital
state: South East England
city: London
country: United Kingdom
facility: St Thomas Hospital
Study officials:
affiliation: Brighton and Sussex University Hospitals
name: David Hildick-Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Milan
name: Claudio Tondo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.