Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
960 participants
INTERVENTIONAL
2025-10-24
2031-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Treatment
Index cardiac surgery + Ablation + Left Atrial Appendage Exclusion with AtriClip
Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System
Box lesion ablation with the Isolator Synergy EnCompass Clamp System and LAAE using the AtriClip LAA Exclusion System at the time of planned cardiac surgery
Control
Index cardiac surgery only
No interventions assigned to this group
Interventions
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Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System
Box lesion ablation with the Isolator Synergy EnCompass Clamp System and LAAE using the AtriClip LAA Exclusion System at the time of planned cardiac surgery
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 65 years and CHA2DS2-VASc ≥ 3
Exclusion Criteria
* Prior procedure involving opening the pericardium or entering the pericardial space
* Patients undergoing off-pump surgery
* Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
* Presence of a permanent pacemaker
* Infiltrative cardiomyopathies (i.e. amyloidosis)
* Planned cardiac surgical procedure using non-sternotomy approaches
* Patients whose planned procedure is a heart transplant or implantation of any long-term ventricular assist devices
* Presence of ventricular arrhythmia
* Active endocarditis
* NYHA Class IV heart failure symptoms
* Preoperative need for an intra-aortic ballon pump or intravenous inotropes
* Active systemic infection at the time of cardiac surgery requiring antibiotics
* Known allergy to Nitinol or nickel sensitivity
* Known medical condition with expected survival of less than 1 year
* Other comorbidities that in the Investigator's opinion make the subject unsuitable candidate to complete the protocol required intervention or visits
* Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial
* Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
* Pregnancy
* Known severe symptomatic carotid disease
65 Years
ALL
Yes
Sponsors
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AtriCure, Inc.
INDUSTRY
Responsible Party
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Locations
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St. Bernards Medical Center
Jonesboro, Arkansas, United States
Morton Plant Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States
St. Joseph's Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States
Orlando Health, Inc.
Orlando, Florida, United States
Wellstar Health System
Marietta, Georgia, United States
Corewell Health
Grand Rapids, Michigan, United States
Ascension Saint Thomas
Nashville, Tennessee, United States
Hamilton General Hospital
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CP-2024-02
Identifier Type: -
Identifier Source: org_study_id
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