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| ID | Type | Description | Link |
|---|---|---|---|
| SJM-CIP-10153 | Other Identifier | Abbott Medical (Note:protocol ID shown in Abbott system) |
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The purpose of this study is to observe the safety and effectiveness of the AMPLATZERâ„¢ Cardiac Plug (ACP) device in Chinese population indicated for use of AMPLATZERâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMPLATZERâ„¢ Cardiac Plug | Subjects who were implanted with AMPLATZERâ„¢ Cardiac Plug will be included in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMPLATZER™ Cardiac Plug | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 7 days of the procedure |
| 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. | Within 2 years of the procedure |
| 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. | Within 2 years of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral anticoagulant; or patients who experience stroke or relevant event despite taking warfarin.
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| Name | Affiliation | Role |
|---|---|---|
| Maren Wagner | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China | ||
| Sir Run Run Shaw Hospital |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| 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 | 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Within 7 days of the procedure |
|
2 years
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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 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Anderson, Clinical Scientist | Abbott | 651-756-3360 | ClinicalTrials.gov_SH_Inquiries@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2018 | Jun 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Zhejiang |
| Hangzhou |
| 310016 |
| China |
| Wuhan Asia Heart Hospital | Wuhan | Hubei | 430000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Ningbo First Hospital | Ningbo | Liuting Saint | 315000 | China |
| The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | 310006 | China |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| HAS-BLED Score | HAS-BLED scale is a scoring system that includes a set of questions to assess the level of risk for bleeding events. The total score ranges from 0 to 9 where a score of 0 indicates low risk, 1-2 indicates moderate risk, and ≥3 indicates high risk. | Mean | Standard Deviation | scores on a scale |
|
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| 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Within 2 years of the procedure |
|
|
|
| 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Within 2 years of the procedure |
|
|
|
| 3 |
| 91 |
| 28 |
| 91 |
| 0 |
| 91 |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Cholelithiasis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease (COPD) | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Facial Paresis | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Gastrointestinal Bleeding | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Heart Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Hemangioma | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Intracerebral Haemorrhage | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Post-Menopausal Bleeding | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| Seizure/Convulsions/Epilepsy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia) | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Stroke | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Subdural Haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Thrombus on Device | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Unmasking Old Stroke Symptoms | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| VASC Hematoma | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Vertigo | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Other - Anaphylactic Shock | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Other - Arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Other - Pancytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |