Post-Operative Atrial FibrillationPhase 4ATLASNCT02701062
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
A Phase 4 study testing AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems and Anticoagulation Therapy in people with Post-Operative Atrial Fibrillation, run by AtriCure, Inc. at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Atrial Fibrillation
- What is being tested?
- AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems and Anticoagulation Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- 22 sitesUnited States
- Study dates
- Feb 2016to 1 Jun 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Emory St Joseph Hospital
Atlanta, Georgia, 30308
University of Maryland
Baltimore, Maryland, 21201
The Christ Hospital -Linder Research Center
Cincinnati, Ohio, 45219
Tri-Health
Cincinnati, Ohio, 45220
PinnacleHealth Hospitals
Harrisburg, Pennsylvania, 17101
St Francis Heart Hospital
Indianapolis, Indiana, 46237
St. Vincent Heart Center, Inc.
Indianapolis, Indiana, 46290
University of Kansas Hospital
Kansas City, Kansas, 66160
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Cardiovascular Surgery Clinic
Memphis, Tennessee, 38120
NYU Langone Medical Center
New York, New York, 10016
Mount Sinai -St. Luke's
New York, New York, 10025
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Orlando Health Heart Institute
Orlando, Florida, 32806
Oregon Health and Science University
Portland, Oregon, 97239
United Heart & Vascular Clinic
Saint Paul, Minnesota, 55102
Sharp Memorial Hospital
San Diego, California, 92123
Swedish Medical Center/Cherry Hill Campus
Seattle, Washington, 98122
Stanford University
Stanford, California, 94304
Cardiology Associates Research
Tupelo, Mississippi, 38801
Aspirus Wausau Hospital
Wausau, Wisconsin, 54401
Valley Health System
Winchester, Virginia, 22601
About this study
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.
Read the 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.
- Conditions
- Post-Operative Atrial Fibrillation
- Being tested
- AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems, Anticoagulation Therapy
- Keywords
- Left Atrial Appendage, Anticoagulation, CHA2DS2- VASc, HASBLED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtriClip® Gillinov-Cosgrove™ LAA Exclusion SystemsDevice
Also called AtriClip FLEX (ACH2), AtriClip Long (LAA), AtriClip Standard (ACH1)
Anticoagulation TherapyDrug
Also called Warfarin/Coumadin, New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban
Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.
| Study group | Role | What they receive |
|---|---|---|
| LAA Exclusion with AtriClip® | Other | LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. Receives: Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems |
| Medical Management | Active comparator | Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator. Receives: Drug: Anticoagulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within any 24 hour period during the first 2 days post-index procedure
Secondary outcomes (7)
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.
Measured: Intraoperative period
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 365 Days Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion26 Apr 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Operative Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sydney Gaynor, MD, Study chair, AtriCure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701062
- Sponsor's protocol ID
- CP2015-2
- Acronym
- ATLAS
- Status last verified
- Jun 2019
- First submitted
- 22 Feb 2016
- Last updated
- 24 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
- ClinicalTrials.gov ID
- NCT02701062
- Acronym / sponsor ID
- ATLAS / CP2015-2
- Conditions
- Post-Operative Atrial Fibrillation
- Keywords
- Left Atrial Appendage, Anticoagulation, CHA2DS2- VASc, HASBLED
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 24 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAA Exclusion with AtriClip® | Other | Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion SystemsLAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. |
| Medical Management | Active comparator | Drug: Anticoagulation TherapyMedical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtriClip® Gillinov-Cosgrove™ LAA Exclusion SystemsAlso: AtriClip FLEX (ACH2), AtriClip Long (LAA), AtriClip Standard (ACH1) | Device | LAA Exclusion with AtriClip® |
| Anticoagulation TherapyAlso: Warfarin/Coumadin, New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixabanAnticoagulation Therapy- Standard of Care at the discretion of the Investigator. | Drug | Medical Management |
Primary outcome
Number of Perioperative Complications Associated With AtriClip Placement
Time frame: 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.
7 secondary outcomes
Number of Subjects With Intraoperative Successful Exclusion of LAA.
Time frame: Intraoperative period
Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)
Time frame: 365 days post index procedure
Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)
Time frame: 30 days Post-Procedure
Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days
Time frame: 365 Days Post-Procedure
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values)
Time frame: 365 Days Post-Procedure
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values)
Time frame: 365 Days Post-Procedure
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates)
Time frame: 365 Days Post-Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sydney Gaynor, MD study chair
AtriCure, Inc.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems and Anticoagulation Therapy in people with Post-Operative Atrial Fibrillation, run by AtriCure, Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Perioperative Complications Associated With AtriClip Placement (time frame: Within any 24 hour period during the first 2 days post-index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.