Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- AtriCure, Inc.
- Enrollment
- 24
- Locations
- 5
- Primary Endpoint
- Primary Safety Endpoint
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Primary Safety Endpoint
Time Frame: Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.
Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.
Absence of Atrial Fibrillation
Time Frame: 12 month follow-up
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.
Secondary Outcomes
- Duration of Procedure(During index procedure)
- Number of Participants With DC Cardioversion(12 months)
- Overall Serious Device or Procedure Related Adverse Event Rate(12 month follow-up)
- Absence of Atrial Fibrillation(After the 3 month blanking period through twelve month follow-up.)
- Number of Participants With Reintervention to Address Atrial Dysrhythmia(12 months)
- Acute Procedure Success(Upon completion of the index procedure, up to ten hours)
- Improvement in AF(12 months)