Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Ablation procedure staged catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 year Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III antiarrhythmic drug (AAD). Patients with failed catheter ablation attempts are eligible if the patients are symptomatic with persistent or longstanding persistent AF. (catheter ablation procedure must be more than 3 months prior to index procedure) Life expectancy of at least two years Patient will and able to provide informed consent Patient is willing and able to attend the scheduled follow-up visits Exclusion Criteria: Prior Cardiothoracic Surgery Patient has NYHA (New York Heart Association) Class IV heart failure Evidence of underlying structural heart disease requiring surgical treatment Surgical procedure within the 30 days prior to the index procedure Ejection fraction < 30% Measured left atrial diameter > 6.0 cm Renal Failure Stroke within previous 6 months Known carotid artery stenosis greater than 80% Evidence of significant active infection or endocarditis Pregnant woman or women desiring to become pregnant in the next 24 months Presence of thrombus in the left atrium determined by echocardiography History of blood dyscrasia Contraindication to anticoagulation, based on Investigator's opinion Mural thrombus or tumor Moderate to Severe COPD

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AtriCure Bipolar System combined with a catheter ablation<br>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart | Device: Ablation procedure staged catheter ablation<br>* AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Subjects With Serious Device or Procedure Related Adverse Event Rate |  | 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 Isolation/block of all pulmonary veins (e.g. 4 of 4 veins); Bi-directional cavotricuspid isthmus block; Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines); Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed. | Day 0 | 
| Number of Subject Without Atrial Fibrillation | AF free with or without the need of antiarrhythmic drugs | 6 and 12 month follow-up | 
| Number of Subjects With Reinterventions |  | 12 month follow-up | 
| Number of Subjects With Direct Current (DC) Cardioversion |  | 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. 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. 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. Negative change from baseline compared to 12-months represents an improvement in AF symptomatology . | 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent AF, Longstanding Persistent AF, Ablation, catheter ablation