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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02701062
Recruitment Status : Completed
First Posted : March 8, 2016
Results First Posted : November 24, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Post-Operative Atrial Fibrillation
Interventions Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Drug: Anticoagulation Therapy
Enrollment 562
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 Details 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®
Hide 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: Index Procedure
Started 376 186
Completed 376 186
Not Completed 0 0
Period Title: Discharge
Started 376 186
Completed 376 186
Not Completed 0 0
Period Title: 30 Day Follow-up
Started 376 186
Completed 366 183
Not Completed 10 3
Period Title: 90 Day Follow-up
Started 366 183
Completed 308 72
Not Completed 58 111
Period Title: 365 Day Follow-up
Started 308 72
Completed 294 69
Not Completed 14 3
Arm/Group Title AtriClip® No AtriClip® Total
Hide 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 Number of Baseline Participants 376 186 562
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 376 participants 186 participants 562 participants
69.2  (7.8) 68.9  (8.7) 69.1  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 376 participants 186 participants 562 participants
Female
113
  30.1%
50
  26.9%
163
  29.0%
Male
263
  69.9%
136
  73.1%
399
  71.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 376 participants 186 participants 562 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 376 participants 186 participants 562 participants
American Indian or Alaskan Native
0
   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
   0.0%
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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 376 participants 186 participants 562 participants
376 186 562
BMI (kg/m²)  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 376 participants 186 participants 562 participants
31.0  (5.6) 30.0  (5.9) 30.6  (5.7)
Risk Assessment: CHA2DS2VASc Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 376 participants 186 participants 562 participants
3.4  (1.2) 3.4  (1.1) 3.4  (1.2)
[1]
Measure Description: 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.
Risk Assessment: HAS-BLED Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 376 participants 186 participants 562 participants
2.8  (0.7) 2.9  (0.6) 2.8  (0.7)
[1]
Measure Description: 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.
Echocardiogram: Left Atrial Diameter (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 376 participants 186 participants 562 participants
4.0  (0.7) 3.9  (0.6) 4.0  (0.6)
Echocardiogram: Left Atrial Diameter (cm)  
Median (Full Range)
Unit of measure:  Cm
Number Analyzed 376 participants 186 participants 562 participants
3.9
(2.1 to 6.0)
3.9
(1.9 to 5.6)
3.9
(1.9 to 6.0)
Echocardiogram: Left Ventricular Ejection Fraction %  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 376 participants 186 participants 562 participants
57.3  (8.4) 58.7  (6.9) 57.8  (8.0)
Echocardiogram: Left Ventricular Ejection Fraction %  
Median (Full Range)
Unit of measure:  %
Number Analyzed 376 participants 186 participants 562 participants
60.0
(30.0 to 81.0)
60.0
(35.0 to 72.0)
60.0
(30.0 to 81.0)
1.Primary Outcome
Title Number of Perioperative Complications Associated With AtriClip Placement
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AtriClip®
Hide Arm/Group Description:

LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.

AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems

Overall Number of Participants Analyzed 376
Measure Type: Number
Unit of Measure: perioperative complications reported
0
2.Secondary Outcome
Title Number of Subjects With Intraoperative Successful Exclusion of LAA.
Hide 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
Hide Outcome Measure Data
Hide 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®
Hide Arm/Group Description:

LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.

AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems

Overall Number of Participants Analyzed 370
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Total Patients, No Flow and No Stump
82.2
(77.9 to 85.9)
Total Patients, No Flow with Stump <= 5mm
95.4
(92.7 to 97.3)
Total Patients, No Flow with Stump <= 10mm
98.9
(97.3 to 99.7)
3.Secondary Outcome
Title Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 56 122 25 46 71
Measure Type: Number
Unit of Measure: percent of participants
19.6 8.2 16.0 6.5 9.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AtriClip Without OAC, Standard of Care With OAC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2593
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 20 178 2 113 115
Measure Type: Number
Unit of Measure: percent of participants
5.0 5.1 0.0 8.0 7.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AtriClip Without OAC, Standard of Care With OAC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 76 300 376 27 159 186
Measure Type: Number
Unit of Measure: percent of participants
15.8 6.7 8.5 14.8 7.5 8.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AtriClip Without OAC, Standard of Care With OAC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1238
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values)
Hide Description Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions.
Time Frame 365 Days Post-Procedure
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 76 300 27 159
Mean (Standard Deviation)
Unit of Measure: days
LOS (Total) Number Analyzed 76 participants 299 participants 27 participants 159 participants
9.1  (7.0) 8.1  (5.2) 8.4  (3.5) 7.3  (4.4)
LOS (Post-Procedure) Number Analyzed 76 participants 300 participants 27 participants 159 participants
7.7  (5.3) 6.4  (3.8) 7.7  (3.1) 5.9  (2.7)
Readmission LOS (per subject) Number Analyzed 9 participants 11 participants 2 participants 4 participants
6.1  (4.1) 4.7  (3.4) 21.0  (18.4) 7.0  (8.3)
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.6603
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.0783
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.4282
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values)
Hide Description Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions.
Time Frame 365 Days Post-Procedure
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 76 300 27 159
Median (Full Range)
Unit of Measure: days
LOS (Total) Number Analyzed 76 participants 299 participants 27 participants 159 participants
7.0
(3.0 to 43)
7.0
(1.0 to 49.0)
9.0
(3.0 to 17.0)
6.0
(2.0 to 32.0)
LOS (Post-Procedure) Number Analyzed 76 participants 300 participants 27 participants 159 participants
6.0
(3.0 to 34.0)
5.0
(1.0 to 45.0)
7.0
(3.0 to 12.0)
5.0
(1.0 to 21.0)
Readmission LOS (per subject) Number Analyzed 9 participants 11 participants 2 participants 4 participants
5.0
(1.0 to 12.0)
5.0
(1.0 to 12.0)
21.0
(8.0 to 34.0)
4.0
(1.0 to 19.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AtriClip Without OAC, Standard of Care With OAC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6603
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.0783
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.4282
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates)
Hide Description Specifically, reoperation for bleeding, neurologic consults for stroke or TIA, and emergency department (ED) visits.
Time Frame 365 Days Post-Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AtriClip With OAC AtriClip Without OAC Standard of Care With OAC Standard of Care Without OAC
Hide 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
Overall Number of Participants Analyzed 76 300 27 159
Measure Type: Number
Unit of Measure: percentage of participants
Reoperation 3.9 2.7 3.7 1.3
ED Visit 9.2 3.3 7.4 4.4
Neurologic Consult 2.6 2.7 3.7 4.4
Hospital Readmission 11.8 3.7 7.4 2.5
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.5442
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.2598
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.5442
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.2921
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
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®
Hide 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 (%) Affected / at Risk (%)
Total   20/376 (5.32%)      4/186 (2.15%)    
Hide Serious Adverse Events
AtriClip® No AtriClip®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/376 (0.27%)      0/0    
Cardiac disorders     
Torsion of the heart * [1]  1/376 (0.27%)  1 0/0  0
*
Indicates events were collected by non-systematic assessment
[1]
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.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AtriClip® No AtriClip®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/376 (0.27%)      0/0    
Cardiac disorders     
Acute Post Pericardotomy Syndrome * [1]  1/376 (0.27%)  1 0/0  0
*
Indicates events were collected by non-systematic assessment
[1]
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nfii Ndikintum, VP Clinical Affairs and Biometrics
Organization: AtriCure
Phone: (513) 644-8192
EMail: nndikintum@atricure.com
Layout table for additonal information
Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT02701062    
Other Study ID Numbers: CP2015-2
First Submitted: February 22, 2016
First Posted: March 8, 2016
Results First Submitted: August 26, 2021
Results First Posted: November 24, 2021
Last Update Posted: November 24, 2021