AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)

• Sponsor: AtriCure, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02701062
• Collaborator: (none)
• Enrollment: 562
• Locations: 22
• Arms: 2
• Duration (Months): 40
• Patients Per Site: 25.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Operative Atrial Fibrillation	Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems; Drug: Anticoagulation Therapy	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 562 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Apr 26, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: LAA Exclusion with AtriClip® LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.	Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems; Other Names: AtriClip FLEX (ACH2) AtriClip Long (LAA) AtriClip Standard (ACH1)
Active Comparator: Medical Management Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator.	Drug: Anticoagulation Therapy; Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.; Other Names: Warfarin/Coumadin New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban

Outcome Measures

Primary Outcome Measures

1. Number of Perioperative Complications Associated With AtriClip Placement [Within any 24 hour period during the first 2 days post-index procedure]

   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.

Secondary Outcome Measures

1. Number of Subjects With Intraoperative Successful Exclusion of LAA. [Intraoperative period]

   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.

2. Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days) [365 days post index procedure]

   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.

3. Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days) [30 days Post-Procedure]

   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.

4. Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days [365 Days Post-Procedure]

   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.

5. Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values) [365 Days Post-Procedure]

   Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions.

6. Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values) [365 Days Post-Procedure]

   Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions.

7. Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates) [365 Days Post-Procedure]

   Specifically, reoperation for bleeding, neurologic consults for stroke or TIA, and emergency department (ED) visits.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients satisfying the following criteria will be considered the screening population and will be eligible for participation:

• Age > 18 years male or female.

• Scheduled for any non-mechanical valve and/or CABG (structural heart) procedure where direct access to the LAA is expected.

• No documented preoperative AF.

• CHA2DS2-VASc score of => 2.

• HASBLED score of => 2.

• Acceptable surgical candidate, including use of general anesthesia.

• Willing and able to provide written informed consent.

Exclusion Criteria:

Patients satisfying the following criteria will not be eligible for participation:

• Redo cardiac surgery.

• Mechanical heart valve or other anticipated or current requirement for anticoagulation therapy during the post-operative (30 day) period.

• Hypercoagulability conditions that may confound the study.

• Ejection Fraction < 30.

• Left Atrium > 6 cm.

• Severe Diastolic Dysfunction.

• Requires anticoagulation therapy.

• Patient had a stroke/cerebrovascular accident (CVA) within previous 30 days prior to signing informed consent.

Intra-Operative Exclusion Criteria

• Presence of thrombus in the left atrium or LAA.

• LAA tissue is deemed friable or has significant adhesions (as evaluated by the surgeon) near or on the LAA making AtriClip placement overly risky.

• Left atrial appendage is outside the range of manufacturer's recommendations - width < 29mm or > 50mm.

• Direct visualization access is not available for AtriClip placement.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sharp Memorial Hospital	San Diego	California	United States	92123
2	Stanford University	Stanford	California	United States	94304
3	Orlando Health Heart Institute	Orlando	Florida	United States	32806
4	Emory St Joseph Hospital	Atlanta	Georgia	United States	30308
5	St Francis Heart Hospital	Indianapolis	Indiana	United States	46237
6	St. Vincent Heart Center, Inc.	Indianapolis	Indiana	United States	46290
7	University of Kansas Hospital	Kansas City	Kansas	United States	66160
8	University of Maryland	Baltimore	Maryland	United States	21201
9	United Heart & Vascular Clinic	Saint Paul	Minnesota	United States	55102
10	Cardiology Associates Research	Tupelo	Mississippi	United States	38801
11	NYU Langone Medical Center	New York	New York	United States	10016
12	Mount Sinai -St. Luke's	New York	New York	United States	10025
13	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
14	The Christ Hospital -Linder Research Center	Cincinnati	Ohio	United States	45219
15	Tri-Health	Cincinnati	Ohio	United States	45220
16	Oregon Health and Science University	Portland	Oregon	United States	97239
17	PinnacleHealth Hospitals	Harrisburg	Pennsylvania	United States	17101
18	Wellmont CVA Heart Institute	Kingsport	Tennessee	United States	37660
19	Cardiovascular Surgery Clinic	Memphis	Tennessee	United States	38120
20	Valley Health System	Winchester	Virginia	United States	22601
21	Swedish Medical Center/Cherry Hill Campus	Seattle	Washington	United States	98122
22	Aspirus Wausau Hospital	Wausau	Wisconsin	United States	54401

Sponsors and Collaborators

• AtriCure, Inc.

Investigators

• Study Chair: Sydney Gaynor, MD, AtriCure, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 15, 2017

More Information

Publications

None provided.

• Responsible Party: AtriCure, Inc.
• ClinicalTrials.gov Identifier: NCT02701062
• Other Study ID Numbers: CP2015-2
• First Posted: Mar 8, 2016
• Last Update Posted: Nov 24, 2021
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by AtriCure, Inc.: Left Atrial Appendage; Anticoagulation; CHA2DS2- VASc; HASBLED
• Additional relevant MeSH terms: Atrial Fibrillation; Warfarin; Rivaroxaban; Dabigatran; Apixaban; Anticoagulants

Study Results

Participant Flow

Recruitment Details

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.

Pre-assignment Detail

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.

Arm/Group Title	AtriClip®	No AtriClip®
Arm/Group Description	LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems	Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator. Other Names: Warfarin/Coumadin New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban No AtriClip® used.
Period Title: Baseline
STARTED	376	186
COMPLETED	376	186
NOT COMPLETED	0	0
Period Title: Baseline
STARTED	376	186
COMPLETED	376	186
NOT COMPLETED	0	0
Period Title: Baseline
STARTED	376	186
COMPLETED	376	186
NOT COMPLETED	0	0
Period Title: Baseline
STARTED	376	186
COMPLETED	366	183
NOT COMPLETED	10	3
Period Title: Baseline
STARTED	366	183
COMPLETED	308	72
NOT COMPLETED	58	111
Period Title: Baseline
STARTED	308	72
COMPLETED	294	69
NOT COMPLETED	14	3

Baseline Characteristics

Arm/Group Title	AtriClip®	No AtriClip®	Total
Arm/Group Description	LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems	Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator. Other Names: Warfarin/Coumadin New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban No AtriClip® used.	Total of all reporting groups
Overall Participants	376	186	562
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.2 (7.8)	68.9 (8.7)	69.1 (8.1)
Sex: Female, Male (Count of Participants)
Female	113 30.1%	50 26.9%	163 29%
Male	263 69.9%	136 73.1%	399 71%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 1.3%	5 2.7%	10 1.8%
Not Hispanic or Latino	370 98.4%	180 96.8%	550 97.9%
Unknown or Not Reported	1 0.3%	1 0.5%	2 0.4%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaskan Native	0 0%	1 0.5%	1 0.2%
Asian	5 1.3%	2 1.1%	7 1.2%
Black or African American	13 3.5%	7 3.8%	20 3.6%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.5%	1 0.2%
White	354 94.1%	171 91.9%	525 93.4%
Other	3 0.8%	3 1.6%	6 1.1%
More Than One Race	1 0.3%	1 0.5%	2 0.4%
Region of Enrollment (participants) [Number]
United States	376 100%	186 100%	562 100%
BMI (kg/m²) (kg/m²) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m²]	31.0 (5.6)	30.0 (5.9)	30.6 (5.7)
Risk Assessment: CHA2DS2VASc Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.4 (1.2)	3.4 (1.1)	3.4 (1.2)
Risk Assessment: HAS-BLED Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.8 (0.7)	2.9 (0.6)	2.8 (0.7)
Echocardiogram: Left Atrial Diameter (cm) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	4.0 (0.7)	3.9 (0.6)	4.0 (0.6)
Echocardiogram: Left Atrial Diameter (cm) (cm) [Median (Full Range) ]
Median (Full Range) [cm]	3.9	3.9	3.9
Echocardiogram: Left Ventricular Ejection Fraction % (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	57.3 (8.4)	58.7 (6.9)	57.8 (8.0)
Echocardiogram: Left Ventricular Ejection Fraction % (%) [Median (Full Range) ]
Median (Full Range) [%]	60.0	60.0	60.0

Outcome Measures

1. Primary Outcome

Title	Number of Perioperative Complications Associated With AtriClip Placement
Description	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.
Time Frame	Within any 24 hour period during the first 2 days post-index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AtriClip®
Arm/Group Description	LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Measure Participants	376
Number [perioperative complications reported]	0

2. Secondary Outcome

Title	Number of Subjects With Intraoperative Successful Exclusion of LAA.
Description	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.
Time Frame	Intraoperative period

Outcome Measure Data

Analysis Population Description

Of the 376 surgical cases where placement of an AtriClip was attempted: 3 AtriClip devices were not implanted 2 patients could not have the intra-operative TEE imaging assessments verified post-operatively and were removed from the LAA exclusion analyses for stump and flow. 1 patient that had a reported stump did not have an assessment for flow recorded. Therefore, 370 patients had complete data available to assess intra-operative LAA exclusion success.

Arm/Group Title	AtriClip®
Arm/Group Description	LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Measure Participants	370
Total Patients, No Flow and No Stump	82.2 21.9%
Total Patients, No Flow with Stump <= 5mm	95.4 25.4%
Total Patients, No Flow with Stump <= 10mm	98.9 26.3%

3. Secondary Outcome

Title	Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)
Description	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.
Time Frame	365 days post index procedure

Outcome Measure Data

Analysis Population Description

Analysis includes only subjects diagnosed with POAF through 365 days.

Arm/Group Title	AtriClip With OAC	AtriClip Without OAC	Standard of Care With OAC	Standard of Care Without OAC	Combined Standard of Care
Arm/Group Description	Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the No AtriClip (Standard of Care) group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined Standard of Care group with or without OAC
Measure Participants	56	122	25	46	71
Number [percent of participants]	19.6 5.2%	8.2 4.4%	16.0 2.8%	6.5 NaN	9.9 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2593
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)
Description	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.
Time Frame	30 days Post-Procedure

Outcome Measure Data

Analysis Population Description

Analysis includes only subjects not diagnosed with POAF through 365 days.

Arm/Group Title	AtriClip With OAC	AtriClip Without OAC	Standard of Care With OAC	Standard of Care Without OAC	Combined Standard of Care
Arm/Group Description	Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the No AtriClip (Standard of Care) group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined Standard of Care group with or without OAC
Measure Participants	20	178	2	113	115
Number [percent of participants]	5.0 1.3%	5.1 2.7%	0.0 0%	8.0 NaN	7.8 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.000
	Comments
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days
Description	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.
Time Frame	365 Days Post-Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AtriClip With OAC	AtriClip Without OAC	Combined AtriClip	Standard of Care With OAC	Standard of Care Without OAC	Combined Standard of Care
Arm/Group Description	Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined AtriClip group with or without OAC	Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the No AtriClip (Standard of Care) group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined Standard of Care group with or without OAC
Measure Participants	76	300	376	27	159	186
Number [percent of participants]	15.8 4.2%	6.7 3.6%	8.5 1.5%	14.8 NaN	7.5 NaN	8.6 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care Without OAC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1238
	Comments
	Method	Fisher Exact
	Comments

6. Secondary Outcome

Title	Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values)
Description	Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions.
Time Frame	365 Days Post-Procedure

Outcome Measure Data

Analysis Population Description

In LOS (Total), 1 Subject removed due to incorrect date entry

Arm/Group Title	AtriClip With OAC	AtriClip Without OAC	Standard of Care With OAC	Standard of Care Without OAC
Arm/Group Description	Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the No AtriClip (Standard of Care) group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure
Measure Participants	76	300	27	159
LOS (Total)	9.1 (7.0)	8.1 (5.2)	8.4 (3.5)	7.3 (4.4)
LOS (Post-Procedure)	7.7 (5.3)	6.4 (3.8)	7.7 (3.1)	5.9 (2.7)
Readmission LOS (per subject)	6.1 (4.1)	4.7 (3.4)	21.0 (18.4)	7.0 (8.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments	LOS (Total)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6603
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments	LOS (Post-Procedure)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0783
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments	Readmission LOS (per subject)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4282
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values)
Description	Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions.
Time Frame	365 Days Post-Procedure

Outcome Measure Data

Analysis Population Description

In LOS (Total), 1 Subject removed due to incorrect date entry

Arm/Group Title	AtriClip With OAC	AtriClip Without OAC	Standard of Care With OAC	Standard of Care Without OAC
Arm/Group Description	Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the No AtriClip (Standard of Care) group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure
Measure Participants	76	300	27	159
LOS (Total)	7.0	7.0	9.0	6.0
LOS (Post-Procedure)	6.0	5.0	7.0	5.0
Readmission LOS (per subject)	5.0	5.0	21.0	4.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6603
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments	LOS (Post-Procedure)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0783
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments	Readmission LOS (per subject)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4282
	Comments
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

Title	Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates)
Description	Specifically, reoperation for bleeding, neurologic consults for stroke or TIA, and emergency department (ED) visits.
Time Frame	365 Days Post-Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AtriClip With OAC	AtriClip Without OAC	Standard of Care With OAC	Standard of Care Without OAC
Arm/Group Description	Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Patients in the No AtriClip (Standard of Care) group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure
Measure Participants	76	300	27	159
Reoperation	3.9 1%	2.7 1.5%	3.7 0.7%	1.3 NaN
ED Visit	9.2 2.4%	3.3 1.8%	7.4 1.3%	4.4 NaN
Neurologic Consult	2.6 0.7%	2.7 1.5%	3.7 0.7%	4.4 NaN
Hospital Readmission	11.8 3.1%	3.7 2%	7.4 1.3%	2.5 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments	Reoperation
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5442
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments	ED Visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2598
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments	Neurologic Consult
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5442
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	AtriClip Without OAC, Standard of Care With OAC
	Comments	Hospital Readmission (per subject)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2921
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Time Frame	365 days post-procedure
Adverse Event Reporting Description	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.
Arm/Group Title	AtriClip®		No AtriClip®
Arm/Group Description	LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems		Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator. Other Names: Warfarin/Coumadin New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban No AtriClip® used.
All Cause Mortality
	AtriClip®		No AtriClip®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/376 (5.3%)		4/186 (2.2%)
Serious Adverse Events
	AtriClip®		No AtriClip®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/376 (0.3%)		0/0 (NaN)
Cardiac disorders
Torsion of the heart	1/376 (0.3%)	1	0/0 (NaN)	0
Other (Not Including Serious) Adverse Events
	AtriClip®		No AtriClip®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/376 (0.3%)		0/0 (NaN)
Cardiac disorders
Acute Post Pericardotomy Syndrome	1/376 (0.3%)	1	0/0 (NaN)	0

Limitations/Caveats

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.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.