Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)

Completed

Conditions: Stroke
Atrial Fibrillation
Thromboembolism

Interventions: Device: Subjects implanted with Amulet Device

Registration Number: NCT02447081

Lead Sponsor: Abbott Medical Devices

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."

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1088

Inclusion Criteria

Subject with history of paroxysmal, persistent or permanent NVAF
Subject who is 18 years or older, or of legal age to give informed consent specific to state and national law
Subject who is eligible for an Amulet LAA Occluder device according to current international guidelines and per physician discretion
Subject who is willing and capable of providing informed consent, participating in all associated study activities

Exclusion Criteria

Subject with evidence of an intracardiac thrombus
Subject with active infection or active endocarditis or other infections producing bacteremia
Subject where the placement of the device would interfere with any intracardiac or intravascular structures
Subject with any medical disorder that would interfere with completion or evaluation of clinical study results
Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
Subject with LAA anatomy that does not accommodate a device per the sizing guidelines

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects implanted with Amulet Device	Subjects implanted with Amulet Device	All subjects who receive the Amulet device will be followed.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Serious Adverse Events	0 to 7 days post procedure	Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure
Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure	7 days through 2 years	Late adverse events were defined as those serious events with an onset date \> 7 days post-procedure
Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death	Implant through 2 years	Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years
Number of Participants With Major Bleeding Events	Implant through 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Procedural Success	During the implant procedure and hospital stay, approximately 1 or 2 days	Procedural success is based on Amulet device being implanted day 0 through hospital discharge, on average one night stay (day 1). Amulet device implanted and subject discharged the following day without an adverse event
Number of Participants With Oral Anti-coagulation Usage	At 24 months
Number of Participants With Technical Success	During implant procedure, approximately 30 to 60 minutes	Technical success is defined as successful implantation of the Amulet device in the left arterial appendage (LAA).

Trial Locations

Locations (51): Hospital Clinico San Borja Arriaran
🇨🇱
Santiago, Chile
Helsinki University Central Hospital
🇫🇮
Helsinki, Uusimaa, Finland
Internistische Klinik Dr. Müller, München-Thalkirchen
🇩🇪
Muenchen, Bavaria, Germany
Turku University Hospital
🇫🇮
Turku, Finland
CHU du Bocage
🇫🇷
Dijon, Burgundy, France
Klinikum Coburg
🇩🇪
Coburg, Bavaria, Germany
CHRU Lille
🇫🇷
Lille, North-Calais, France
Universitaetsklinikum Ulm
🇩🇪
Ulm, Bavaria, Germany
Zentrum fur Herzgesundheit/Kardiologie am Alice Hospital Darmstadt
🇩🇪
Darmstadt, Hesse, Germany
CardioVaskuläres Centrum St. Katharinen
🇩🇪
Frankfurt, Hesse, Germany
Universitätsklinikum Düsseldorf
🇩🇪
Duesseldorf, North Rhine-Westphal, Germany
Zentralklinik Bad Berka Gmbh
🇩🇪
Bad Berka, Thuringia, Germany
Zentralklinik Bad Berka
🇩🇪
Bad Berka, Germany
Rigshospitalet
🇩🇰
Copenhagen, Denmark
Hopital Haut Leveque
🇫🇷
Pessac, Aquitaine, France
CHU d'Amiens
🇫🇷
Amiens, Picardy, France
Klinikum Frankfurt Höchst
🇩🇪
Frankfurt, Germany
Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, Unveristiy of Milan
🇮🇹
Milan, Italy
Ulleval Universitetssykehus
🇳🇴
Oslo, Norway
Hospital Universitario Son Espases
🇪🇸
Palma de Mallorca, Balearic Island, Spain
Hospital Universitario de Salamanca
🇪🇸
Salamanca, Castile And Leon, 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
Fiona Stanley Hospital
🇦🇺
Murdoch, Western Australia, Australia
St. Marien Hospital Bonn
🇩🇪
Bonn, Germany
Universitaire Ziekenhuizen Gasthuisberg
🇧🇪
Leuven, Belgium
Segeberger Kliniken Gmbh
🇩🇪
Bad Segeberg, Germany
Herzzentrum Dresden
🇩🇪
Dresden, Germany
Charité - Universitätsmedizin Berlin (CBF)
🇩🇪
Berlin, Germany
Segeberger Kliniken GmbH
🇩🇪
Bad Segeberg, Germany
Cardioangiologisches Centrum Bethanien
🇩🇪
Frankfurt, Germany
Harzklinikum Dorothea Christiane Erxleben GmbH
🇩🇪
Quedlinburg, Germany
San Raffaele Hospital
🇮🇹
Milan, Italy
Rems-Murr-Klinikum Winnenden
🇩🇪
Winnenden, Germany
Mater Hospital
🇮🇪
Dublin, Ireland
The Chaim Sheba Medical Center
🇮🇱
Tel Hashomer, Israel
The Cardinal Stefan Wyszynski Institute of Cardiology
🇵🇱
Warsaw, Poland
Slaskie Centrum Chorob Serca
🇵🇱
Warszawa, Poland
Hospital Universitario Virgen Macarena
🇪🇸
Sevilla, Andalusia, Spain
Ospedale dell'Angelo and Ospedale SS Giovanni e Paolo Venezia
🇮🇹
Mestre, Veneto, Italy
Amsterdam Academic Medical Centre
🇳🇱
Veenendaal, Netherlands
Università degli Studi di Padova
🇮🇹
Padova, Veneto, Italy
Azienda Ospedaliera S. Anna e S. Sebastiano
🇮🇹
Caserta, Italy
Ospedale del Cuoro Fondazione C. N. R. Regione Toscana G. Monasterio
🇮🇹
Massa, Italy
Ospedale Luigi Sacco
🇮🇹
Milano, Italy
Nuovo Ospedale Civile Sant'Agostino Estense
🇮🇹
Baggiovara, 1355, Modena, Italy