Non-valvular Atrial Fibrillation (NVAF)
Conditions
Keywords
Non-valvular atrial fibrillation (NVAF), Anticoagulant, Warfarin, Stroke
Brief summary
The purpose of this study is to observe the safety and effectiveness of the AMPLATZER™ Cardiac Plug (ACP) device in Chinese population indicated for use of AMPLATZER™ Cardiac Plug after its market approval by China FDA (CFDA). This is a prospective, multi-centre, single arm, post approval, observational study. The clinical study will be conducted at up to 35 sites in China. Approximately 343 subjects will be enrolled in this study. The total study duration is expected to be approximately 7 years. The study population included patients who have non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral anticoagulant; or patients who experience stroke or other thromboembolic event despite taking warfarin. Scheduled office visits occur at 45 days (+45 days), 6M (+/- 3 weeks) 12M (+/- 6 weeks) and 24 M(+/- 6 weeks) post procedure; Phone contact follow up visits occur at, 36 M (+/- 6 weeks), 48M (+/- 6 weeks) and 60 M (+/- 6 weeks) post procedures.
Interventions
DEVICEAMPLATZER™ Cardiac Plug
The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient who meets the current indications and per physician discretion for ACP implant 2. Patient who is ≥ 18 years of age at the time of enrolment 3. Patient who is able to provide written Informed Consent prior to any study related procedures
Exclusion criteria
1. Patient who is unable to comply with the follow-up schedule 2. Patient with the presence of intracardiac thrombus 3. Patient with active endocarditis or other infections producing bacteraemia 4. Patient who has low risk of stroke (CHA2DS2-VASC score is 0 or 1) or low risk of bleeding (HAS-BLED score\<3) 5. Patient where placement of the device would interfere with any intracardiac or intravascular structures 6. Patient who is under medical conditions not appropriate to participate in the study in the opinion of the investigator 7. Patient with LAA anatomy that does not accommodate a device per the sizing guidelines 8. Patient who has a life expectancy of less than 2 years due to any condition 9. Patient who are currently participating in a clinical investigation that includes an active treatment arm 10. Patient who already had a left atrial appendage closure device implanted prior to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention | Within 7 days of the procedure | The primary short-term safety endpoint was the composite of death, stroke (ischemic or haemorrhagic), systemic embolism and procedure or device-related complications requiring major cardiovascular or endovascular intervention. |
| Long-Term Safety Endpoint: Composite Rate of Device Embolization/Device Erosion/Device Interference With Surrounding Structure/Device Thrombus/Device Fracture/Device Infection/Device Perforation/Device Laceration/Device Allergy | Within 2 years of the procedure | The primary long-term safety endpoint was the composite of of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection (endocarditis and pericarditis), device perforation, device laceration, or device allergy. |
| Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism | Within 2 years of the procedure | The primary long-term effectiveness endpoint was the composite rate of ischemic stroke or systemic embolism. |
Countries
China
Participant flow
Recruitment details
A total of 94 subjects were consented, and 91 were enrolled in the study. The first and last Amplatzer Cardiac Plug implants as part of the study occured on 14-Nov-2016 and 12-Mar-2019, respectively. The final 24-month follow-up visit occurred on 29-Jan-2021.
Participants by arm
| Arm | Count |
|---|---|
| AMPLATZER™ Cardiac Plug Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.
AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr) | 91 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Missed visit | 16 |
| Overall Study | Withdrawal by Subject | 25 |
Baseline characteristics
| Characteristic | AMPLATZER™ Cardiac Plug | — |
|---|---|---|
| Age, Continuous | 69.6 Years STANDARD_DEVIATION 8.5 | — |
| HAS-BLED Score | 3.5 scores on a scale STANDARD_DEVIATION 0.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment China | 91 Participants | — |
| Sex: Female, Male Female | 35 Participants | — |
| Sex: Female, Male Male | 56 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 91 |
| other Total, other adverse events | 0 / 91 |
| serious Total, serious adverse events | 28 / 91 |
Outcome results
Primary
Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism
The primary long-term effectiveness endpoint was the composite rate of ischemic stroke or systemic embolism.
Time frame: Within 2 years of the procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AMPLATZER™ Cardiac Plug | Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism | 1.1 percentage of participants |
Primary
Long-Term Safety Endpoint: Composite Rate of Device Embolization/Device Erosion/Device Interference With Surrounding Structure/Device Thrombus/Device Fracture/Device Infection/Device Perforation/Device Laceration/Device Allergy
The primary long-term safety endpoint was the composite of of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection (endocarditis and pericarditis), device perforation, device laceration, or device allergy.
Time frame: Within 2 years of the procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AMPLATZER™ Cardiac Plug | Long-Term Safety Endpoint: Composite Rate of Device Embolization/Device Erosion/Device Interference With Surrounding Structure/Device Thrombus/Device Fracture/Device Infection/Device Perforation/Device Laceration/Device Allergy | 2.2 percentage of participants |
Primary
Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention
The primary short-term safety endpoint was the composite of death, stroke (ischemic or haemorrhagic), systemic embolism and procedure or device-related complications requiring major cardiovascular or endovascular intervention.
Time frame: Within 7 days of the procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AMPLATZER™ Cardiac Plug | Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention | 1.1 percentage of participants |