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| ID | Type | Description | Link |
|---|---|---|---|
| CRD_1028 | Other Identifier | Abbott |
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This study was terminated due to the shift in Sponsor's business strategy.
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The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.
Atrial fibrillation (AF) is the most common sustained heart rhythm disorder. During AF, chaotic electrical activity results in rapid, uncoordinated, and insufficient contractions of the atrial chambers. Stagnation of blood flow in the left atrium (LA) can lead to hypercoagulability. The left atrial appendage (LAA), given its location and complex shape is often the primary site of stasis and thus increases the risk for thrombus formation. Approximately 90% of all thrombi in patients with non-valvular AF (NVAF) forming in the LA originate in the LAA.
Patients with NVAF are at an increased risk of systemic embolism and stoke due to the potential for clot forming in the LAA. OAC is the recommended first-line therapy for NVAF at increased risk of stroke, however, many patients have relative or absolute contraindications to taking OACs. LAAO offers a non-pharmacological option for stroke risk reduction in these patients unable to take OAC.
The Amulet occluder is Abbott's second-generation LAA occlusion device. It received CE Mark in 2013, and FDA approval in August 2021. Observational studies performed in multiple geographies show that the Amulet occluder can be safely implanted with good procedural outcomes and reduce the risk of stroke as compared to a predicted rate without the need for anticoagulation in most patients. This led to the National Medical Products Administration (NMPA) approval of the Amulet occluder in 2020.
The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amulet Left Atrial Appendage Occluder | Subject will receive the Left Atrial Appendage (LAA) closure procedure with Amulet Left Atrial Appendage Occluder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder | Device | Subject will receive the Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Short-Term Safety Endpoint: Occurrence of Major Adverse Events | The primary short-term safety endpoint is the occurrence of one or more of the following major adverse events within 7 days after the procedure: all-cause mortality, procedure or device-related complications requiring open cardiac surgery or major endovascular intervention, ischemic or hemorrhagic stroke, or systemic embolism. | 7 days |
| Primary Long-Term Safety Endpoint: Occurrence of Device Embolization, Device Erosion, Significant Device Interference With Surrounding Structure, Device Thrombus, Device Fracture, Device Related Infections, Device Breakage, or Device Related Allergy | The primary long-term safety endpoint is the occurrence of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device related infections (endocarditis and pericarditis), device breakage, or device related allergy through 2 years. The protocol-defined time frame for endpoint assessment was 2 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period. | 2 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.) |
| Primary Effectiveness Endpoint: Composite of Ischemic Stroke or Systemic Embolism | The primary effectiveness endpoint is a composite of ischemic stroke or systemic embolism through 2 years. The protocol-defined time frame for endpoint assessment was 2 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period. | 2 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.) |
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| Measure | Description | Time Frame |
|---|---|---|
| Descriptive Endpoint: Composite of Damage to Blood Vessel or Organ or Damage to Adjacent Organs at Implant, Device Dislodgement, Device Fracture, Device Erosion, or Pericardial Tamponade | Composite of damage to blood vessel or organ or damage to adjacent organs at implant, device dislodgement, device fracture, device erosion, or pericardial tamponade through 5 years post-procedure. The protocol-defined time frame for endpoint assessment was 5 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period. |
Inclusion Criteria:
Exclusion Criteria:
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This clinical investigation will enroll subjects of all genders from the Chinese nationality general population ≥18 years old. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.
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| Name | Affiliation | Role |
|---|---|---|
| Zhihui ZHANG | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hong Kong-Shenzhen Hospital | Shenzhen | Guangdong | 518009 | China | ||
| Wuhan Asia Heart Hospital |
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A total of 50 subjects were enrolled across five investigational sites in China between January 30, 2024, and January 10, 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amulet Left Atrial Appendage Occluder | Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amulet Left Atrial Appendage Occluder | Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Short-Term Safety Endpoint: Occurrence of Major Adverse Events | The primary short-term safety endpoint is the occurrence of one or more of the following major adverse events within 7 days after the procedure: all-cause mortality, procedure or device-related complications requiring open cardiac surgery or major endovascular intervention, ischemic or hemorrhagic stroke, or systemic embolism. | The number of participants analyzed includes subjects with Amulet occluder implanted. | Posted | Count of Participants | Participants | 7 days |
|
from enrollment until end of follow-up, up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amulet Left Atrial Appendage Occluder | Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial Effusion | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Clinical Program Director | Abbott | +1 612 805 6398 | ryan.gage@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 26, 2023 | May 4, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2024 | May 4, 2026 | SAP_001.pdf |
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| 5 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.) |
| Descriptive Endpoint: Rate of Device Success | Rate of device success - defined as device deployed and implanted in correct position | During implant procedure, approximately 30 to 60 minutes |
| Descriptive Endpoint: Rate of Device Closure | Rate of device closure - defined as residual jet around the device of ≤ 5mm, based on the 3-month transesophageal echocardiogram (TEE) defined by Doppler flow | 3 months |
| Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs | Descriptive Endpoint: Percentage of subjects taking OAC or antiplatelet drugs through 5 years. The protocol-defined time frame for endpoint assessment was 5 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period. | 5 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.) |
| Wuhan |
| Hubei |
| 430022 |
| China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| Xiangya Hospital Zhuzhou Central South University | Zhuzhou | Hunan | 412007 | China |
| Xianyang Hospital Of Yan'an University | Xianyang | Shaanxi | China |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Primary reason for seeking an alternative or unable to take long-term warfarin/other anticoagulant | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Primary Long-Term Safety Endpoint: Occurrence of Device Embolization, Device Erosion, Significant Device Interference With Surrounding Structure, Device Thrombus, Device Fracture, Device Related Infections, Device Breakage, or Device Related Allergy | The primary long-term safety endpoint is the occurrence of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device related infections (endocarditis and pericarditis), device breakage, or device related allergy through 2 years. The protocol-defined time frame for endpoint assessment was 2 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period. | The number of participants analyzed includes subjects with Amulet occluder implanted. | Posted | Count of Participants | Participants | 2 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.) |
|
|
|
| Primary | Primary Effectiveness Endpoint: Composite of Ischemic Stroke or Systemic Embolism | The primary effectiveness endpoint is a composite of ischemic stroke or systemic embolism through 2 years. The protocol-defined time frame for endpoint assessment was 2 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period. | The number of participants analyzed includes subjects with Amulet occluder implanted. | Posted | Count of Participants | Participants | 2 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.) |
|
|
|
| Other Pre-specified | Descriptive Endpoint: Composite of Damage to Blood Vessel or Organ or Damage to Adjacent Organs at Implant, Device Dislodgement, Device Fracture, Device Erosion, or Pericardial Tamponade | Composite of damage to blood vessel or organ or damage to adjacent organs at implant, device dislodgement, device fracture, device erosion, or pericardial tamponade through 5 years post-procedure. The protocol-defined time frame for endpoint assessment was 5 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period. | The number of participants analyzed includes subjects with Amulet occluder implanted. | Posted | Count of Participants | Participants | 5 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.) |
|
|
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| Other Pre-specified | Descriptive Endpoint: Rate of Device Success | Rate of device success - defined as device deployed and implanted in correct position | Analysis included subjects who underwent an implant attempt regardless of the device attempted or implanted. | Posted | Count of Participants | Participants | During implant procedure, approximately 30 to 60 minutes |
|
|
|
| Other Pre-specified | Descriptive Endpoint: Rate of Device Closure | Rate of device closure - defined as residual jet around the device of ≤ 5mm, based on the 3-month transesophageal echocardiogram (TEE) defined by Doppler flow | Analysis included subjects who had evaluable leak assessments at 3 months. | Posted | Count of Participants | Participants | 3 months |
|
|
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| Other Pre-specified | Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs | Descriptive Endpoint: Percentage of subjects taking OAC or antiplatelet drugs through 5 years. The protocol-defined time frame for endpoint assessment was 5 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Count of Participants | Participants | 5 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.) |
|
|
|
| 1 |
| 50 |
| 10 |
| 50 |
| 8 |
| 50 |
| Congestive Heart Failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Gastrointestinal Bleeding | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Incarcerated Inguinal Hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| False Aneurysm | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Intracerebral Haemorrhage | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Vascular Access Site Bruising | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Vascular Access Site Pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Laboratory Test Abnormal | Investigations | MedDRA | Non-systematic Assessment |
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| Arteriovenous Fistula | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Peripheral Vein Thrombus Extension | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Thrombus | Vascular disorders | MedDRA | Non-systematic Assessment |
|
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| Dual antiplatelet |
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| No antithrombotic medication |
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| Discharge |
|
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| 3 months |
|
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| 6 months |
|
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| 12 months |
|
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