Atrial Fibrillation, Stroke, Thromboembolism
Conditions
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.
Interventions
DEVICESubjects implanted with Amulet Device
Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Sponsors
Abbott Medical Devices
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 discharge, approximately 1 or 2 days after the procedure | — |
| 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). |
Countries
Australia, Belgium, Chile, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
A total of 1088 subjects were enrolled and attempted implant with Amulet left atrial appendage occluder conducted at 61 sites between June 01, 2015 and September 19, 2016. The final study visit at 2 years post-implant was completed by 864 subjects, with the last study visit occurring in October 2018.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Implanted With Amulet Device All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device. | 1,088 |
| Total | 1,088 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 161 |
| Overall Study | Lost to Follow-up | 36 |
| Overall Study | unsuccessful implant procedure | 10 |
| Overall Study | Visit not completed | 17 |
Baseline characteristics
| Characteristic | Subjects Implanted With Amulet Device | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 966 Participants | — |
| Age, Categorical Between 18 and 65 years | 122 Participants | — |
| Age, Continuous | 75.2 years STANDARD_DEVIATION 8.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 70 participants | — |
| Region of Enrollment Belgium | 17 participants | — |
| Region of Enrollment Chile | 6 participants | — |
| Region of Enrollment Denmark | 62 participants | — |
| Region of Enrollment Finland | 55 participants | — |
| Region of Enrollment France | 65 participants | — |
| Region of Enrollment Germany | 378 participants | — |
| Region of Enrollment Hong Kong | 41 participants | — |
| Region of Enrollment Israel | 1 participants | — |
| Region of Enrollment Italy | 178 participants | — |
| Region of Enrollment Netherlands | 1 participants | — |
| Region of Enrollment Norway | 5 participants | — |
| Region of Enrollment Poland | 26 participants | — |
| Region of Enrollment Spain | 105 participants | — |
| Region of Enrollment Sweden | 13 participants | — |
| Region of Enrollment Switzerland | 6 participants | — |
| Region of Enrollment United Kingdom | 59 participants | — |
| Sex: Female, Male Female | 386 Participants | — |
| Sex: Female, Male Male | 702 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 161 / 1,088 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 538 / 1,088 |
Outcome results
Primary
Number of Participants With Acute Serious Adverse Events
Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure
Time frame: 0 to 7 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Implanted With Amulet Device | Number of Participants With Acute Serious Adverse Events | 83 Participants |
Primary
Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death
Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years
Time frame: Implant through 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Implanted With Amulet Device | Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death | 122 Participants |
Primary
Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure
Late adverse events were defined as those serious events with an onset date \> 7 days post-procedure
Time frame: 7 days through 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Implanted With Amulet Device | Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure | 504 Participants |
Primary
Number of Participants With Major Bleeding Events
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.
Time frame: Implant through 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Implanted With Amulet Device | Number of Participants With Major Bleeding Events | 110 Participants |
Secondary
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects Implanted With Amulet Device | Number of Participants With Oral Anti-coagulation Usage | OAC without anti-platelet therapy | 38 Participants |
| Subjects Implanted With Amulet Device | Number of Participants With Oral Anti-coagulation Usage | OAC with anti-platelet therapy | 19 Participants |
Secondary
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 6 months
Population: The number of participates completing a study visit at the Time Frame
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects Implanted With Amulet Device | Number of Participants With Oral Anti-coagulation Usage | OAC without anti-platelet therapy | 33 Participants |
| Subjects Implanted With Amulet Device | Number of Participants With Oral Anti-coagulation Usage | OAC with anti-platelet therapy | 23 Participants |
Secondary
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 12 months
Population: The number of participates completing a study visit at the Time Frame
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects Implanted With Amulet Device | Number of Participants With Oral Anti-coagulation Usage | OAC without anti-platelet therapy | 35 Participants |
| Subjects Implanted With Amulet Device | Number of Participants With Oral Anti-coagulation Usage | OAC with anti-platelet therapy | 21 Participants |
Secondary
Number of Participants With Oral Anti-coagulation Usage
Time frame: At discharge, approximately 1 or 2 days after the procedure
Population: The number of participates completing a study visit at the Time Frame
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects Implanted With Amulet Device | Number of Participants With Oral Anti-coagulation Usage | OAC without anti-platelet therapy | 49 Participants |
| Subjects Implanted With Amulet Device | Number of Participants With Oral Anti-coagulation Usage | OAC with antiplatelet therapy | 71 Participants |
Secondary
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 1 to 3 months
Population: The number of participates completing a study visit at the Time Frame
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects Implanted With Amulet Device | Number of Participants With Oral Anti-coagulation Usage | OAC without anti-platelet therapy | 29 Participants |
| Subjects Implanted With Amulet Device | Number of Participants With Oral Anti-coagulation Usage | OAC with anti-platelet therapy | 34 Participants |
Secondary
Number of Participants With Procedural Success
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
Time frame: During the implant procedure and hospital stay, approximately 1 or 2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Implanted With Amulet Device | Number of Participants With Procedural Success | 1039 Participants |
Secondary
Number of Participants With Technical Success
Technical success is defined as successful implantation of the Amulet device in the left arterial appendage (LAA).
Time frame: During implant procedure, approximately 30 to 60 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Implanted With Amulet Device | Number of Participants With Technical Success | 1078 Participants |