Feasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- AtriCure, Inc.
- Enrollment
- 30
- Locations
- 6
- Primary Endpoint
- Number of Subjects With Absence of Atrial Fibrillation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Subjects With Absence of Atrial Fibrillation
Time Frame: 12 month follow-up
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.
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.
Time Frame: 30 days post-index procedure or hospital discharge
Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.
Secondary Outcomes
- Number Subjects With Serious Device or Procedure Related Adverse Event Rate(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(12 month follow-up)
- Number of Subjects With Acute Procedure Success(Day 0)
- Number of Subject Without Atrial Fibrillation(6 and 12 month follow-up)