Atrial Fibrillation, Stroke, Thromboembolism
Conditions
Keywords
Atrial Fibrillation, Stroke, Left Atrial Appendage, Cardiac Plug, Amulet, Thromboembolism
Brief summary
The aim of this multicenter, non-randomized observational post-approval is to compile real world outcome data on the use of an AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF). The AMPLATZER LAA Occluders is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA.
Interventions
DEVICEAMPLATZER™ LAA Occluder
The AMPLATZER™ LAA Occluder is intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular Atrial Fibrillation (AF). It may be considered for use in patients who have a high risk of stroke and bleeding and are deemed by their physician to have an appropriate rationale to seek a non-pharmacologic alternative to long term anticoagulants.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Documented history of nonvalvular atrial fibrillation * Subjects in whom an AMPLATZER LAA Occluder device is intended to be implanted or Subjects who underwent an AMPLATZER LAA Occluder implant attempt after the device was approved in the applicable geography
Exclusion criteria
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death | Implant through 24 months | The occurrence of one or more the composite of stroke (including ischemic or hemorrhagic), systemic embolism, or cardiovascular or unexplained death at 24 months from the time of enrollment |
| Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism | Implant through 24 months | The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment |
| Primary Safety Endpoint: Number of Subjects With All Cause Death, Ischemic Stroke, Systemic Embolism, or Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Repair | Implant through 7 days | The occurrence of one of the following events between the time of implant and within 7 days of the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular repair |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the Relative Risk Decrease Of Observed Rate of Ischemic Stroke at 24 Months With the CHA2DS2-VASc Predicted Rate for the Implant Population | Implant through 24 months | The secondary endpoint comparing the observed rate of ischemic stroke at 24 months with the congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category (CHA2DS2-VASc) score predicted rate for the implant population. The following calculation was used to calculate the Relative Risk Decrease: (Predicted Rate minus Observed Rate) divided by Predicted Rate = Relative Risk Decrease. |
Countries
Argentina, Belgium, Canada, Chile, Germany, Italy, Spain
Participant flow
Recruitment details
A total of 520 patients were enrolled and underwent Amplatzer LAA Occluder implant attempt at 22 investigational sites between December 8, 2016 and July 2, 2020.
Participants by arm
| Arm | Count |
|---|---|
| LAA Occluder PAS Subjects who were treated with AMPLATZER LAA Occluders will be included. | 520 |
| Total | 520 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Anatomical Heart Structure of the Patient; LAA Occluder Was Not Implanted; Heart Transplant | 3 |
| Overall Study | Death | 103 |
| Overall Study | Device Explant | 1 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Unsuccessful Procedure | 5 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | LAA Occluder PAS |
|---|---|
| Age, Continuous | 75.90 Years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 248 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 224 Participants |
| Medical History HAS-BLED score | 520 Participants |
| Medical History History of Major Bleeding | 392 Participants |
| Medical History History of Stroke | 160 Participants |
| Medical History History of TIA | 65 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 16 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 187 Participants |
| Race (NIH/OMB) White | 303 Participants |
| Sex: Female, Male Female | 185 Participants |
| Sex: Female, Male Male | 335 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 103 / 520 |
| other Total, other adverse events | 3 / 520 |
| serious Total, serious adverse events | 201 / 520 |
Outcome results
Primary
Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death
The occurrence of one or more the composite of stroke (including ischemic or hemorrhagic), systemic embolism, or cardiovascular or unexplained death at 24 months from the time of enrollment
Time frame: Implant through 24 months
Population: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LAA Occluder PAS | Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death | 14.28 percentage of participants |
Primary
Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism
The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
Time frame: Implant through 24 months
Population: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LAA Occluder PAS | Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism | 4.41 percentage of participants |
Primary
Primary Safety Endpoint: Number of Subjects With All Cause Death, Ischemic Stroke, Systemic Embolism, or Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Repair
The occurrence of one of the following events between the time of implant and within 7 days of the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular repair
Time frame: Implant through 7 days
Population: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LAA Occluder PAS | Primary Safety Endpoint: Number of Subjects With All Cause Death, Ischemic Stroke, Systemic Embolism, or Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Repair | 3 Participants |
Secondary
Comparison of the Relative Risk Decrease Of Observed Rate of Ischemic Stroke at 24 Months With the CHA2DS2-VASc Predicted Rate for the Implant Population
The secondary endpoint comparing the observed rate of ischemic stroke at 24 months with the congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category (CHA2DS2-VASc) score predicted rate for the implant population. The following calculation was used to calculate the Relative Risk Decrease: (Predicted Rate minus Observed Rate) divided by Predicted Rate = Relative Risk Decrease.
Time frame: Implant through 24 months
Population: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LAA Occluder PAS | Comparison of the Relative Risk Decrease Of Observed Rate of Ischemic Stroke at 24 Months With the CHA2DS2-VASc Predicted Rate for the Implant Population | -70 percent change in the rate |