Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study

Study Overview
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Brief Summary
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The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. 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 Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation

Conditions
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Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: Hybrid: AtriCure Bipolar System & EP ablation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent Patient is willing and able to provide written informed consent. Patient has a life expectancy of at least 2 years. Patient is willing and able to attend the scheduled follow-up visits. Exclusion Criteria: Prior Cardiothoracic Surgery. Patient has NYHA Class IV heart failure. Evidence of underlying structural heart disease requiring surgical treatment. 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>procedure using the AtriCure Bipolar System plus a catheter ablation | Device: Hybrid: AtriCure Bipolar System & EP ablation procedure<br>* AtriCure Bipolar System plus a catheter ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer. | Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer. | 
| Absence of Atrial Fibrillation | Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy. | 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Serious Device or Procedure Related Adverse Event Rate |  | 12 month follow-up | 
| Acute Procedure Success |  | Upon completion of the index procedure, up to ten hours | 
| Absence of Atrial Fibrillation | Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor. | After the 3 month blanking period through twelve month follow-up. | 
| Number of Participants With Reintervention to Address Atrial Dysrhythmia | Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months | 12 months | 
| Number of Participants With DC Cardioversion |  | 12 months | 
| Improvement in AF | Improvement in Atrial Fibrillation Symptom Checklist Frequency (Minimum value: -1.0, Maximum value: 25.0) and Severity Scores (Minimum value: -6.0, Maximum value: 19.0) | 12 months | 
| Duration of Procedure |  | During index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation, Ablation, Catheter ablation