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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAA Occluder PAS | Subjects who were treated with AMPLATZER LAA Occluders will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMPLATZERâ„¢ LAA Occluder | Device | The AMPLATZERâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Implant through 24 months |
| 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 | Implant through 24 months |
| 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 | Implant through 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The subject population will include participants that are > 18 years old and diagnosed with NVAF.
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Palmer | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Cardiovascular de Rosario | Rosario | Santa Fe Province | 2000 | Argentina | ||
| Hôpital Civil Marie Curie |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | LAA Occluder PAS | Subjects who were treated with AMPLATZER LAA Occluders will be included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LAA Occluder PAS | Subjects who were treated with AMPLATZER LAA Occluders will be included. |
| 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 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 | The number of participants analyzed includes subjects for whom data were available at that time of analysis. | Posted | Number | percentage of participants | Implant through 24 months |
|
|
24 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 | LAA Occluder PAS | Subjects who were treated with AMPLATZER LAA Occluders will be included. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemias | Blood and lymphatic system disorders | Abbott AE Code List | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombus on Device | Product Issues | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Gage | 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 | Nov 19, 2018 | Jul 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2020 | Jul 7, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013923 | Thromboembolism |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
|
| Implant through 24 months |
| Lodelinsart |
| Hainaut |
| 6042 |
| Belgium |
| Royal Columbian | New Westminster | British Columbia | V3L 3W5 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 2E8 | Canada |
| Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H2L 4M1 | Canada |
| CHUM | Montreal | Quebec | H2X 3E4 | Canada |
| The Royal Victoria Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| Instituto Nacional del Torax | Providencia | Santiago Metropolitan | Chile |
| Hospital Clinico San Borja Arriarán | Santiago | 8320000 | Chile |
| Cardioangiologisches Centrum am Bethanien Krankenhaus | Frankfurt am Main | Hesse | 60389 | Germany |
| St. Marien-Hospital-Bonn | Bonn | North Rhine-Westphalia | 53115 | Germany |
| Segeberger Kliniken GmbH | Bad Segeberg | Schleswig-Holstein | 23795 | Germany |
| Zentralklinik Bad Berka GmbH | Bad Berka | Thuringia | 99438 | Germany |
| Azienda Ospedaliera Monaldi | Naples | Campania | 80131 | Italy |
| Ospedale San Giovanni Bosco | Torino | Piedmonte | 10154 | Italy |
| Università degli Studi di Padova | Padova | Veneto | 35128 | Italy |
| Hospital Universitario de Salamanca | Salamanca | Castille and León | 37007 | Spain |
| Hospital Clinic I Provincial de Barcelona | Barcelona | Catalonia | 8028 | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Unsuccessful Procedure |
|
| Device Explant |
|
| Anatomical Heart Structure of the Patient; LAA Occluder Was Not Implanted; Heart Transplant |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Medical History | Count of Participants | Participants |
|
| Counts |
|---|
| 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 | The number of participants analyzed includes subjects for whom data were available at that time of analysis. | Posted | Number | percentage of participants | Implant through 24 months |
|
|
|
| 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 | The number of participants analyzed includes subjects for whom data were available at that time of analysis. | Posted | Count of Participants | Participants | Implant through 7 days |
|
|
|
| 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. | The number of participants analyzed includes subjects for whom data were available at that time of analysis. | Posted | Number | percent change in the rate | Implant through 24 months |
|
|
|
| 103 |
| 520 |
| 201 |
| 520 |
| 3 |
| 520 |
| Iron-Deficiency Anemia | Blood and lymphatic system disorders | Abbott AE Code List | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Decompensated Heart Failure | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Heart Failure | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Mitral Valve Regurgitation/Mitral Insufficiency | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Pericardial Tamponade | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Persistent Atrial Fibrillation | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia) | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Thrombus | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
| Retinal Hemorrhage | Eye disorders | Abbott AE Code List | Systematic Assessment |
|
| Bowel Obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Abbott AE Code List | Systematic Assessment |
|
| Gastrointestinal Bleeding | Gastrointestinal disorders | Abbott AE Code List | Systematic Assessment |
|
| Ascites | General disorders | Abbott AE Code List | Systematic Assessment |
|
| Change in Gait | General disorders | Abbott AE Code List | Systematic Assessment |
|
| Dizziness | General disorders | Abbott AE Code List | Systematic Assessment |
|
| Failure to Thrive | General disorders | Abbott AE Code List | Systematic Assessment |
|
| Multiple Organ Failure | General disorders | Abbott AE Code List | Systematic Assessment |
|
| Other | General disorders | Abbott AE Code List | Systematic Assessment |
|
| Hepatic and Biliary Disorders | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pancreatic Cancer | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Acute Bacterial Endocarditis (ABE) | Infections and infestations | Abbott AE Code List | Systematic Assessment |
|
| Acute Peritonitis | Infections and infestations | Abbott AE Code List | Systematic Assessment |
|
| Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Chlamydial Pneumonia | Infections and infestations | Abbott AE Code List | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Abbott AE Code List | Systematic Assessment |
|
| Pneumonia Caused By Gram-Negative Bacilli | Infections and infestations | Abbott AE Code List | Systematic Assessment |
|
| Sepsis | Infections and infestations | Abbott AE Code List | Systematic Assessment |
|
| Septicemia | Infections and infestations | Abbott AE Code List | Systematic Assessment |
|
| Urinary Tract Infections | Infections and infestations | Abbott AE Code List | Systematic Assessment |
|
| Viral Syndrome | Infections and infestations | Abbott AE Code List | Systematic Assessment |
|
| Closed Head Injury | Injury, poisoning and procedural complications | Abbott AE Code List | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Abbott AE Code List | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | Abbott AE Code List | Systematic Assessment |
|
| Trauma | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Abnormal Lab Value | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Abbott AE Code List | Systematic Assessment |
|
| Acute Subdural Hematoma | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Delirium | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Incidental Finding of Stroke | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Intracerebral Haemorrhage | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Ischemic Stroke | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Myoclonus | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Paresthesia/Paraesthesia | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Seizure/Convulsions/Epilepsy | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Stroke | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Transient Ischemic Attack (TIA) | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Vertigo | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Device Migration | Product Issues | MedDRA 11.0 | Systematic Assessment |
|
| Thrombus on Device | Product Issues | Abbott AE Code List | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Abbott AE Code List | Systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | Abbott AE Code List | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Abbott AE Code List | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Abbott AE Code List | Systematic Assessment |
|
| Renal Insufficiency | Renal and urinary disorders | Abbott AE Code List | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Abbott AE Code List | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Abbott AE Code List | Systematic Assessment |
|
| Hemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Idiopathic Interstitial Lung Diseases | Respiratory, thoracic and mediastinal disorders | Abbott AE Code List | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Abbott AE Code List | Systematic Assessment |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Abbott AE Code List | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Abbott AE Code List | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Abbott AE Code List | Systematic Assessment |
|
| Hemarthrosis | Skin and subcutaneous tissue disorders | Abbott AE Code List | Systematic Assessment |
|
| Seroma | Skin and subcutaneous tissue disorders | Abbott AE Code List | Systematic Assessment |
|
| Arterial Hypertension/Hypertension | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| Bleeding | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| Carotid Aneurysm | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| Deep Vein/Venous Thrombosis | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| Hematoma | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| Hemorrhage | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| Hypertensive Crisis | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| Perforation of Vessel | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| Peripheral Arterial Occlusion | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| Syncope | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| VASC Bleeding | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| VASC Pseudoaneurysm | Vascular disorders | Abbott AE Code List | Systematic Assessment |
|
| Transient Ischemic Attack (TIA) | Nervous system disorders | Abbott AE Code List | Systematic Assessment |
|
| Unstable Angina | Cardiac disorders | Abbott AE Code List | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |