Trial Outcomes & Findings for AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS) (NCT NCT02701062)

Last Updated: 2021-11-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

562 participants

Primary outcome timeframe

Within any 24 hour period during the first 2 days post-index procedure

Results posted on

2021-11-24

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	AtriClip® LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems	No AtriClip® 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.
Baseline STARTED	376	186
Baseline COMPLETED	376	186
Baseline NOT COMPLETED	0	0
Index Procedure STARTED	376	186
Index Procedure COMPLETED	376	186
Index Procedure NOT COMPLETED	0	0
Discharge STARTED	376	186
Discharge COMPLETED	376	186
Discharge NOT COMPLETED	0	0
30 Day Follow-up STARTED	376	186
30 Day Follow-up COMPLETED	366	183
30 Day Follow-up NOT COMPLETED	10	3
90 Day Follow-up STARTED	366	183
90 Day Follow-up COMPLETED	308	72
90 Day Follow-up NOT COMPLETED	58	111
365 Day Follow-up STARTED	308	72
365 Day Follow-up COMPLETED	294	69
365 Day Follow-up NOT COMPLETED	14	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AtriClip® n=376 Participants LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems	No AtriClip® n=186 Participants 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 n=562 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 7.8 • n=5 Participants	68.9 years STANDARD_DEVIATION 8.7 • n=7 Participants	69.1 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	50 Participants n=7 Participants	163 Participants n=5 Participants
Sex: Female, Male Male	263 Participants n=5 Participants	136 Participants n=7 Participants	399 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	370 Participants n=5 Participants	180 Participants n=7 Participants	550 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaskan Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	354 Participants n=5 Participants	171 Participants n=7 Participants	525 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · More Than One Race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	376 participants n=5 Participants	186 participants n=7 Participants	562 participants n=5 Participants
BMI (kg/m²)	31.0 kg/m² STANDARD_DEVIATION 5.6 • n=5 Participants	30.0 kg/m² STANDARD_DEVIATION 5.9 • n=7 Participants	30.6 kg/m² STANDARD_DEVIATION 5.7 • n=5 Participants
Risk Assessment: CHA2DS2VASc Score	3.4 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	3.4 units on a scale STANDARD_DEVIATION 1.1 • n=7 Participants	3.4 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants
Risk Assessment: HAS-BLED Score	2.8 units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants	2.9 units on a scale STANDARD_DEVIATION 0.6 • n=7 Participants	2.8 units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants
Echocardiogram: Left Atrial Diameter (cm)	3.9 cm n=5 Participants	3.9 cm n=7 Participants	3.9 cm n=5 Participants
Echocardiogram: Left Ventricular Ejection Fraction %	60.0 % n=5 Participants	60.0 % n=7 Participants	60.0 % n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	AtriClip Without OAC Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care With OAC Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	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	Combined Standard of Care Combined Standard of Care group with or without OAC	AtriClip With OAC n=376 Participants Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined Standard of Care Combined Standard of Care group with or without OAC
Number of Perioperative Complications Associated With AtriClip Placement	—	—	—	—	0 perioperative complications reported	—

SECONDARY outcome

Timeframe: Intraoperative period

Population: 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.

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.

Outcome measures

Outcome measures
Measure	AtriClip Without OAC Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care With OAC Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	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	Combined Standard of Care Combined Standard of Care group with or without OAC	AtriClip With OAC n=370 Participants Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined Standard of Care Combined Standard of Care group with or without OAC
Number of Subjects With Intraoperative Successful Exclusion of LAA. Total Patients, No Flow and No Stump	—	—	—	—	82.2 percentage of participants Interval 77.9 to 85.9	—
Number of Subjects With Intraoperative Successful Exclusion of LAA. Total Patients, No Flow with Stump <= 5mm	—	—	—	—	95.4 percentage of participants Interval 92.7 to 97.3	—
Number of Subjects With Intraoperative Successful Exclusion of LAA. Total Patients, No Flow with Stump <= 10mm	—	—	—	—	98.9 percentage of participants Interval 97.3 to 99.7	—

SECONDARY outcome

Timeframe: 365 days post index procedure

Population: Analysis includes only subjects diagnosed with 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.

Outcome measures

Outcome measures
Measure	AtriClip Without OAC n=122 Participants Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care With OAC n=25 Participants Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care Without OAC n=46 Participants 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 n=71 Participants Combined Standard of Care group with or without OAC	AtriClip With OAC n=56 Participants Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined Standard of Care Combined Standard of Care group with or without OAC
Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)	8.2 percent of participants	16.0 percent of participants	6.5 percent of participants	9.9 percent of participants	19.6 percent of participants	—

SECONDARY outcome

Timeframe: 30 days Post-Procedure

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

Outcome measures

Outcome measures
Measure	AtriClip Without OAC n=178 Participants Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care With OAC n=2 Participants Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care Without OAC n=113 Participants 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 n=115 Participants Combined Standard of Care group with or without OAC	AtriClip With OAC n=20 Participants Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined Standard of Care Combined Standard of Care group with or without OAC
Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)	5.1 percent of participants	0.0 percent of participants	8.0 percent of participants	7.8 percent of participants	5.0 percent of participants	—

SECONDARY outcome

Timeframe: 365 Days Post-Procedure

Outcome measures

Outcome measures
Measure	AtriClip Without OAC n=300 Participants Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care With OAC n=376 Participants Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care Without OAC n=27 Participants 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 n=159 Participants Combined Standard of Care group with or without OAC	AtriClip With OAC n=76 Participants Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined Standard of Care n=186 Participants Combined Standard of Care group with or without OAC
Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days	6.7 percent of participants	8.5 percent of participants	14.8 percent of participants	7.5 percent of participants	15.8 percent of participants	8.6 percent of participants

SECONDARY outcome

Timeframe: 365 Days Post-Procedure

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

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

Outcome measures

Outcome measures
Measure	AtriClip Without OAC n=300 Participants Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care With OAC n=27 Participants Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care Without OAC n=159 Participants 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 Combined Standard of Care group with or without OAC	AtriClip With OAC n=76 Participants Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined Standard of Care Combined Standard of Care group with or without OAC
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values) LOS (Total)	8.1 days Standard Deviation 5.2	8.4 days Standard Deviation 3.5	7.3 days Standard Deviation 4.4	—	9.1 days Standard Deviation 7.0	—
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values) LOS (Post-Procedure)	6.4 days Standard Deviation 3.8	7.7 days Standard Deviation 3.1	5.9 days Standard Deviation 2.7	—	7.7 days Standard Deviation 5.3	—
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values) Readmission LOS (per subject)	4.7 days Standard Deviation 3.4	21.0 days Standard Deviation 18.4	7.0 days Standard Deviation 8.3	—	6.1 days Standard Deviation 4.1	—

SECONDARY outcome

Timeframe: 365 Days Post-Procedure

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

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

Outcome measures

Outcome measures
Measure	AtriClip Without OAC n=300 Participants Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care With OAC n=27 Participants Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care Without OAC n=159 Participants 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 Combined Standard of Care group with or without OAC	AtriClip With OAC n=76 Participants Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined Standard of Care Combined Standard of Care group with or without OAC
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values) LOS (Total)	7.0 days Interval 1.0 to 49.0	9.0 days Interval 3.0 to 17.0	6.0 days Interval 2.0 to 32.0	—	7.0 days Interval 3.0 to 43.0	—
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values) LOS (Post-Procedure)	5.0 days Interval 1.0 to 45.0	7.0 days Interval 3.0 to 12.0	5.0 days Interval 1.0 to 21.0	—	6.0 days Interval 3.0 to 34.0	—
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values) Readmission LOS (per subject)	5.0 days Interval 1.0 to 12.0	21.0 days Interval 8.0 to 34.0	4.0 days Interval 1.0 to 19.0	—	5.0 days Interval 1.0 to 12.0	—

SECONDARY outcome

Timeframe: 365 Days Post-Procedure

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

Outcome measures

Outcome measures
Measure	AtriClip Without OAC n=300 Participants Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care With OAC n=27 Participants Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Standard of Care Without OAC n=159 Participants 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 Combined Standard of Care group with or without OAC	AtriClip With OAC n=76 Participants Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure	Combined Standard of Care Combined Standard of Care group with or without OAC
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates) Reoperation	2.7 percentage of participants	3.7 percentage of participants	1.3 percentage of participants	—	3.9 percentage of participants	—
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates) ED Visit	3.3 percentage of participants	7.4 percentage of participants	4.4 percentage of participants	—	9.2 percentage of participants	—
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates) Neurologic Consult	2.7 percentage of participants	3.7 percentage of participants	4.4 percentage of participants	—	2.6 percentage of participants	—
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates) Hospital Readmission	3.7 percentage of participants	7.4 percentage of participants	2.5 percentage of participants	—	11.8 percentage of participants	—

Adverse Events

AtriClip®

Serious events: 1 serious events

Other events: 1 other events

Deaths: 20 deaths

No AtriClip®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	AtriClip® n=376 participants at risk LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems	No AtriClip® 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.
Cardiac disorders Torsion of the heart	0.27% 1/376 • Number of events 1 • 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.	— 0/0 • 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.

Other adverse events

Other adverse events
Measure	AtriClip® n=376 participants at risk LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems	No AtriClip® 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.
Cardiac disorders Acute Post Pericardotomy Syndrome	0.27% 1/376 • Number of events 1 • 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.	— 0/0 • 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.

Additional Information

Nfii Ndikintum, VP Clinical Affairs and Biometrics

AtriCure

Phone: (513) 644-8192

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER