Phase
Condition
Atrial Fibrillation
Chest Pain
Dysrhythmia
Treatment
Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System
Clinical Study ID
Ages > 65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Planned and clinically indicated for cardiac surgical procedure requiring cardiacbypass and opening of the pericardium
Age ≥ 65 years and CHA2DS2-VASc ≥ 3
Exclusion
Exclusion Criteria:
Documented history of atrial fibrillation or atrial flutter anytime prior to thecardiac surgery
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 anylong-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 unsuitablecandidate to complete the protocol required intervention or visits
Current enrollment in an investigation or trial or an investigational devices orinvestigational drug that would interfere with this trial
Mental impairment or other psychiatric conditions which may not allow the patient tounderstand the nature, significance, and scope of the trial.
Pregnancy
Known severe symptomatic carotid disease
Study Design
Connect with a study center
Hamilton General Hospital
Hamilton, Ontario L8L 2X2
CanadaActive - Recruiting
London Health Sciences Centre, University Hospital
London, Ontario N6A 5A5
CanadaActive - Recruiting
Montreal Heart Institute
Montreal, Quebec H1T 1C8
CanadaActive - Recruiting
St. Bernards Medical Center
Jonesboro, Arkansas 72401
United StatesActive - Recruiting
Sharp Memorial Hospital
San Diego, California 92123
United StatesActive - Recruiting
Morton Plant Hospital - BayCare Health System, Inc.
Clearwater, Florida 33759
United StatesActive - Recruiting
St. Joseph's Hospital - BayCare Health System, Inc.
Clearwater, Florida 33759
United StatesActive - Recruiting
Orlando Health, Inc.
Orlando, Florida 32806
United StatesActive - Recruiting
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesActive - Recruiting
Morton Plant Hospital - BayCare Health System, Inc.
Clearwater 4151316, Florida 4155751 33759
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30308
United StatesActive - Recruiting
Piedmont Hospital
Atlanta, Georgia 30309
United StatesActive - Recruiting
Wellstar Health System
Marietta, Georgia 30062
United StatesActive - Recruiting
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesActive - Recruiting
Norton Healthcare
Louisville, Kentucky 40205
United StatesActive - Recruiting
MedStar Health Research Institute
Baltimore, Maryland 21218
United StatesActive - Recruiting
Corewell Health
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Trinity Health
Ypsilanti, Michigan 48197
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Northwell Health
Manhasset, New York 11030
United StatesActive - Recruiting
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York 10032
United StatesSite Not Available
Bethesda North Hospital
Cincinnati, Ohio 45242
United StatesActive - Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesActive - Recruiting
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
Ascension Saint Thomas
Nashville, Tennessee 37205
United StatesActive - Recruiting
Baylor Research Institute - Baylor Scott and White Research Institute
Dallas, Texas 75204
United StatesActive - Recruiting
Charleston Area Medical Center
Charleston, West Virginia 25304
United StatesActive - Recruiting
Aspirus Hospital
Wausau, Wisconsin 54401
United StatesActive - Recruiting

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