N/A
N=1,088
Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)
Atrial Fibrillation · Thromboembolism · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02447081 ↗Enrolled (actual)
1,088
Serious AEs
49.5%
Results posted
Dec 2019
Primary outcome: Primary: Number of Participants With Acute Serious Adverse Events — 83 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Subjects implanted with Amulet Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Serious Adverse Events |
83 | — |
| PRIMARY Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure |
504 | — |
| PRIMARY Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death |
122 | — |
| PRIMARY Number of Participants With Major Bleeding Events |
110 | — |
| SECONDARY Number of Participants With Technical Success |
1078 | — |
| SECONDARY Number of Participants With Procedural Success |
1039 | — |
| SECONDARY Number of Participants With Oral Anti-coagulation Usage |
38; 19 | — |
| SECONDARY Number of Participants With Oral Anti-coagulation Usage |
38; 19 | — |
| SECONDARY Number of Participants With Oral Anti-coagulation Usage |
38; 19 | — |
| SECONDARY Number of Participants With Oral Anti-coagulation Usage |
38; 19 | — |
| SECONDARY Number of Participants With Oral Anti-coagulation Usage |
38; 19 | — |
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."
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02447081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.