The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure performed approximately 1-10 days after, in treating atrial fibrillation, and how effective is this staged procedure. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Stanford University Medical Center
Stanford, California, United States
Colorado Springs Cardiology/Colorado Cardiac Alliance
Colorado Springs, Colorado, United States
Vanderbilt Heart Institute
Nashville, Tennessee, United States
Sentara Norfolk Hospital
Norfolk, Virginia, United States
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.
Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.
Time frame: 30 days post-index procedure or hospital discharge
Number of Subjects With Absence of Atrial Fibrillation
Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.
Time frame: 12 month follow-up
Number Subjects With Serious Device or Procedure Related Adverse Event Rate
Time frame: 12 month follow-up
Number of Subjects With Acute Procedure Success
Defined as subject meeting all of the following criteria upon completion of the index-EP procedure 1. Isolation/block of all pulmonary veins (e.g. 4 of 4 veins); 2. Bi-directional cavotricuspid isthmus block; 3. Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines); 4. Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.
Time frame: Day 0
Number of Subject Without Atrial Fibrillation
AF free with or without the need of antiarrhythmic drugs
Time frame: 6 and 12 month follow-up
Number of Subjects With Reinterventions
Time frame: 12 month follow-up
Number of Subjects With Direct Current (DC) Cardioversion
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Universitair Ziekenhuis Brussel
Brussels, Belgium
Academic Medical Center
Amsterdam, Netherlands
Time frame: 12 month follow-up
Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores
Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline. 1. This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology. 2. The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology. 3. Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .
Time frame: 12 month follow-up