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Patients without a documented history of Atrial Fibrillation (AF) and will undergo a valve or Coronary Artery Bypass Graft (CABG) procedure with direct visual access to the Left Atrial Appendage (LAA) will be eligible to participate. Patients enrolled will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who develop Post-operative Atrial Fibrillation (POAF) and receive the AtriClip will be followed for 365 days post index procedure.
Patients without a documented history of AF but who present with a CHA2DS2- VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) of => 2 and HASBLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) of => 2 and will undergo a valve or CABG (structural heart) procedure with direct visual access to the LAA will be eligible to participate based upon the inclusion and exclusion criteria defined in this protocol. Up to 2000 patients will enroll at up to 40 sites and will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who not develop Post-operative Atrial Fibrillation (POAF) will be followed for 30 days for safety. Subjects who develop POAF and receive the AtriClip will be followed for 365 days post index procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAA Exclusion with AtriClip® | Other | LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. |
|
| Medical Management | Active Comparator | Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Perioperative Complications Associated With AtriClip Placement | Defined as: stroke, major bleeding that requires re-operation and/or transfusion of > 2 U packed red blood cells (PRBC), myocardial infarction (MI), or death. | Within any 24 hour period during the first 2 days post-index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Intraoperative Successful Exclusion of LAA. | Successful exclusion of LAA is defined as no (0 mm) flow between LAA and LA and < 5 mm LAA remnant by intraoperative TEE with Doppler. | Intraoperative period |
| Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days) |
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Inclusion Criteria:
Patients satisfying the following criteria will be considered the screening population and will be eligible for participation:
Exclusion Criteria:
Patients satisfying the following criteria will not be eligible for participation:
Intra-Operative Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sydney Gaynor, MD | AtriCure, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Memorial Hospital | San Diego | California | 92123 | United States | ||
| Stanford University |
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Prior to randomization, transesophageal echocardiography (TEE) with Doppler was performed to assess for presence of thrombus. If a thrombus was present in the left atrium (LA) or LAA, the subject was not included in the study.
Patients without a documented history of Atrial Fibrillation (AF) but who presented with a CHA2DS2- VASc of => 2 and HASBLED of => 2 and were to undergo a valve or CABG (structural heart) procedure with direct visual access to the Left Atrial Appendage (LAA) were recruited to participate based upon the inclusion and exclusion criteria defined in the protocol. A total of 562 participants were enrolled across 23 sites. The study visits took place between February 2016 and April 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | AtriClip® | LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems |
| FG001 | No AtriClip® | Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator. Other Names:
No AtriClip® used. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline |
|
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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 | Feb 15, 2017 |
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| Anticoagulation Therapy | Drug | Anticoagulation Therapy- Standard of Care at the discretion of the Investigator. |
|
|
Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. |
| 365 days post index procedure |
| Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days) | Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. | 30 days Post-Procedure |
| Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days | Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. | 365 Days Post-Procedure |
| Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values) | Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions. | 365 Days Post-Procedure |
| Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values) | Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions. | 365 Days Post-Procedure |
| Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates) | Specifically, reoperation for bleeding, neurologic consults for stroke or TIA, and emergency department (ED) visits. | 365 Days Post-Procedure |
| Stanford |
| California |
| 94304 |
| United States |
| Orlando Health Heart Institute | Orlando | Florida | 32806 | United States |
| Emory St Joseph Hospital | Atlanta | Georgia | 30308 | United States |
| St Francis Heart Hospital | Indianapolis | Indiana | 46237 | United States |
| St. Vincent Heart Center, Inc. | Indianapolis | Indiana | 46290 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| United Heart & Vascular Clinic | Saint Paul | Minnesota | 55102 | United States |
| Cardiology Associates Research | Tupelo | Mississippi | 38801 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Mount Sinai -St. Luke's | New York | New York | 10025 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| The Christ Hospital -Linder Research Center | Cincinnati | Ohio | 45219 | United States |
| Tri-Health | Cincinnati | Ohio | 45220 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| PinnacleHealth Hospitals | Harrisburg | Pennsylvania | 17101 | United States |
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | United States |
| Cardiovascular Surgery Clinic | Memphis | Tennessee | 38120 | United States |
| Valley Health System | Winchester | Virginia | 22601 | United States |
| Swedish Medical Center/Cherry Hill Campus | Seattle | Washington | 98122 | United States |
| Aspirus Wausau Hospital | Wausau | Wisconsin | 54401 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Index Procedure |
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| Discharge |
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| 30 Day Follow-up |
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| 90 Day Follow-up |
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| 365 Day Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | AtriClip® | LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems |
| BG001 | No AtriClip® | Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator. Other Names:
No AtriClip® used. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI (kg/m²) | Mean | Standard Deviation | kg/m² |
| |||||||||||||||
| Risk Assessment: CHA2DS2VASc Score | The CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) score has been validated to define the risk of stroke in Atrial Fibrillation (AF) patients in numerous papers. This is a 9 point scale with 0 indicating a low risk and 9 indicating a very high risk. A CHA2DS2-VASc of >2 estimates an annual risk of stroke of between 4.5-18.2% in patients with AF. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Risk Assessment: HAS-BLED Score | The HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly, Drugs/Alcohol Concomitantly) score assesses the risk of major bleeding on a 9 point scale with 0 indicating a low risk and 9 indicating a very high risk. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Echocardiogram: Left Atrial Diameter (cm) | Mean | Standard Deviation | cm |
| |||||||||||||||
| Echocardiogram: Left Atrial Diameter (cm) | Median | Full Range | cm |
| |||||||||||||||
| Echocardiogram: Left Ventricular Ejection Fraction % | Mean | Standard Deviation | % |
| |||||||||||||||
| Echocardiogram: Left Ventricular Ejection Fraction % | Median | Full Range | % |
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| 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 | Number of Perioperative Complications Associated With AtriClip Placement | Defined as: stroke, major bleeding that requires re-operation and/or transfusion of > 2 U packed red blood cells (PRBC), myocardial infarction (MI), or death. | Posted | Number | perioperative complications reported | Within any 24 hour period during the first 2 days post-index procedure |
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| |||||||||||||||||||||||||||
| Secondary | Number of Subjects With Intraoperative Successful Exclusion of LAA. | Successful exclusion of LAA is defined as no (0 mm) flow between LAA and LA and < 5 mm LAA remnant by intraoperative TEE with Doppler. | Of the 376 surgical cases where placement of an AtriClip was attempted:
Therefore, 370 patients had complete data available to assess intra-operative LAA exclusion success. | Posted | Number | 95% Confidence Interval | percentage of participants | Intraoperative period |
|
| ||||||||||||||||||||||||||
| Secondary | Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days) | Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. | Analysis includes only subjects diagnosed with POAF through 365 days. | Posted | Number | percent of participants | 365 days post index procedure |
| ||||||||||||||||||||||||||||
| Secondary | Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days) | Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. | Analysis includes only subjects not diagnosed with POAF through 365 days. | Posted | Number | percent of participants | 30 days Post-Procedure |
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| Secondary | Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days | Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. | Posted | Number | percent of participants | 365 Days Post-Procedure |
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| Secondary | Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values) | Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions. | In LOS (Total), 1 Subject removed due to incorrect date entry | Posted | Mean | Standard Deviation | days | 365 Days Post-Procedure |
| |||||||||||||||||||||||||||
| Secondary | Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values) | Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions. | In LOS (Total), 1 Subject removed due to incorrect date entry | Posted | Median | Full Range | days | 365 Days Post-Procedure |
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| Secondary | Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates) | Specifically, reoperation for bleeding, neurologic consults for stroke or TIA, and emergency department (ED) visits. | Posted | Number | percentage of participants | 365 Days Post-Procedure |
|
365 days post-procedure
Subject safety was monitored throughout the course of this study by monitoring for adverse events and product complaints related to the AtriClip device. Therefore, subjects that did not receive the device were not monitored for Adverse Events. All-cause mortality was recorded for all subjects. The AtriClip device used during the index procedure for the clinical study is cleared for marketing by the FDA and was being used within the current labeling and indications for use.
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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 | AtriClip® | LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems | 20 | 376 | 1 | 376 | 1 | 376 |
| EG001 | No AtriClip® | Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator. Other Names:
No AtriClip® used. | 4 | 186 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Torsion of the heart | Cardiac disorders | Non-systematic Assessment | Unanticipated severe event that occurred post-placement, before discharge. Related to surgical technical phenomenon & the AtriClip application procedure. Medication administered & heart was untwisted during index procedure. Resolved without sequelae. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Post Pericardotomy Syndrome | Cardiac disorders | Non-systematic Assessment | Mild event that occurred post-placement, before discharge. Possibly related to the AtriClip and related to the AtriClip Device. Medication was administered. Resolved without sequelae. |
|
ATLAS was an exempt post-market study therefore the use of oral anticoagulants could not be directed or standardized across the study sites. This led to a wide variation to the medical post-operative management in both the types drugs used for oral anticoagulation and dosage prescribed. Furthermore, the sample size for this feasibility study is relatively small to allow for a definitive conclusion on the impact of LAA occlusion and thromboembolic events.
Before publishing or presenting, PI shall submit copies to Sponsor at least 60 days in advance. If Sponsor makes a good faith determination within such period that this release would be detrimental to its or its affiliates' intellectual property interests, PI shall refrain from publishing for another 90 days to allow Sponsor to file patent applications or take other steps to protect interests. Alternatively, these sections and/or inaccurately reported results may be redacted or modified.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nfii Ndikintum, VP Clinical Affairs and Biometrics | AtriCure | (513) 644-8192 | nndikintum@atricure.com |
| Aug 26, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000095062 | Anticoagulation Bridge |
| D014859 | Warfarin |
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D000093142 | Bridge Therapy |
| D013812 | Therapeutics |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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| More Than One Race |
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Patients in the No AtriClip (Standard of Care) group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure |
| OG004 | Combined Standard of Care | Combined Standard of Care group with or without OAC |
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Patients in the No AtriClip (Standard of Care) group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure |
| OG004 | Combined Standard of Care | Combined Standard of Care group with or without OAC |
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| OG004 | Standard of Care Without OAC | Patients in the No AtriClip (Standard of Care) group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure |
| OG005 | Combined Standard of Care | Combined Standard of Care group with or without OAC |
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