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

Completed

• Conditions: Stroke; Atrial Fibrillation; Thromboembolism

• 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."

Study Timeline

• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-18
• Study Start: 2015-06-01
• Primary Completion: 2018-10-23
• Study Completion: 2018-10-23
• Results First Submitted: 2019-11-01
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-11
• Last Update Submitted: 2019-12-11
• Results First Posted: 2019-12-30
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1088

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

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

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