Phase
Condition
Arrhythmia
Chest Pain
Cardiac Disease
Treatment
AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Symptomatic Persistent Atrial Fibrillation or Longstanding Persistent AtrialFibrillation refractory to a minimum of one Class I or Class III AADs.
Exclusion
Exclusion Criteria:
AF >10 years.
Refractory hypertension, defined as systolic (>150 mm Hg) or diastolic (> 90 mm Hg)blood pressure that remains uncontrolled despite sustained therapy
History of pulmonary hypertension
Pulmonary vein stenosis in one or more of the pulmonary veins
EP catheter ablation procedure to treat atrial fibrillation within 3 months
Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in apneumothorax or hemothorax.
Sleep apnea, home oxygen therapy, moderate to severe COPD, (FEV1/FVC < 70%predicted) or patient is considered intolerant to single lung ventilation.
NYHA Class IV heart failure.
Uncorrected, reversible cause(s) of atrial fibrillation, or is currently beingtreated for arrhythmias other than atrial fibrillation (AF) or atrial flutter.
Documented history of previous catheter ablation with perforation, history ofpericarditis, pericardial effusion, or tamponade.
Structural heart disease requiring surgical treatment (i.e. valve disease requiringrepair or replacement within 12 months following surgical ablation procedure).
CAD requiring intervention (either surgical, i.e. CABG, or catheter).
Ejection fraction < 30%
Measured left atrial diameter > 5.5 cm
Stroke/cerebrovascular accident (CVA) within previous six months, carotid arterystenosis greater than 80%.
BMI is >40
Thrombus in the left atrium or the left atrial appendage, determined byechocardiography (either at baseline TTE (or equivalent diagnostic test) orintraoperative TEE).
Blood dyscrasia or clotting disorder (i.e. Idiopathic Thrombocytopenic Purpura [ITP]or Thrombotic Thrombocytopenic Purpura [TTP]).
Contraindication to anticoagulation that in the opinion of the investigator posesundue risk to the patient from participating in the endocardial EP procedure.
Documented thromboembolism within the previous six months prior to signing informedconsent.
Has the following atrial myxoma, mural thrombus or mural tumor.
A condition or congenital anomaly which prevents required surgical or catheteraccess.
A co-morbid condition that, in the opinion of the investigator, poses undue risk ofgeneral anesthesia or port access cardiac surgery.
Currently abusing drugs or alcohol.
Currently or has participated in a clinical study in the last 3 months prior tosigning informed consent.
A psychological disorder that could interfere with provision of informed consent,completion of tests, therapy, or follow-up.
A condition that, in the opinion of the investigator, may jeopardize the patient'swell-being and/or the soundness of this clinical study.
Pre-existing esophageal condition that required (or requires) endoscopic therapy orsurgical treatment.
Study Design
Study Description
Connect with a study center
Universitair Ziekenhuis Brussel (UZ Brussels)
Brussels,
BelgiumSite Not Available
Academic Medical Center (AMC)
Amsterdam,
NetherlandsSite Not Available
Long Beach Memorial Medical Center
Long Beach, California 90806
United StatesSite Not Available
Cedars-Sinai Heart Institute
Los Angeles, California 90048
United StatesSite Not Available
Alta Bates Sutter Medical Center, East Bay Hospital
Oakland, California 94609
United StatesSite Not Available
St. Helena Hospital, Adventist Heart Institute
Saint Helena, California 94574
United StatesSite Not Available
St. Helena Hospital, Adventist Heart Institute
St. Helena, California 94574
United StatesSite Not Available
Stanford University Department of CV medicine
Stanford, California 94305
United StatesSite Not Available
Shands at the University of Florida
Gainesville, Florida 32610
United StatesSite Not Available
Orlando Heart Institute
Orlando, Florida 32806
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
Saint Alphonsus Regional Medical Center
Boise, Idaho 83706
United StatesSite Not Available
OSF St. Anthony Hospital
Rockford, Illinois
United StatesSite Not Available
The Christ Hospital
Cincinnati, Ohio 45219
United StatesSite Not Available
Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals
Cincinnati, Ohio
United StatesSite Not Available
Pinnacle Health
Harrisburg, Pennsylvania 17104
United StatesSite Not Available
Sentara Cardiovascular Research Institute
Norfolk, Virginia 23507
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesSite Not Available
Aspirus Research Institute
Wausau, Wisconsin 54401
United StatesSite Not Available

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