Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation
Persistent Atrial Fibrillation
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Atrial Fibrillation, Anti-Arrhythmia Agents, Catheter Ablation, surgical hybrid ablation
Eligibility Criteria
Inclusion Criteria:
- The subject is 18 years of age or older
- Left atrium < 6.0 em (Trans Thoracic Echo - TTE- parasternal4 chamber view performed within 6 months)
- History of AF for at least 6 months
- Failed or refractory to one AAD (class I and/or Ill)
- Documentation of persistent AF
- Provided written informed consent
- Be eligible for the hybrid procedure
Exclusion Criteria:
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one year life expectancy
- Previous cardiac surgery
- Previous abdominal surgery which will prevent epicardial access
- History of pericarditis
- Previous cerebrovascular accident (CVA), excluding fully resolved TIA
- Patients who have active infection or sepsis
- Patients with esophageal ulcers strictures and varices
- Patients with renal dysfunction who are not on dialysis (defined as GFR ::5 40)
- Patients who are contraindicated for anticoagulants such as heparin and coumadin
- Patients who are being treated for ventricular arrhythmias
- Patients who have had a previous left atrial catheter ablation for AF (does not include ablation for AFL or other supraventricular arrhythmias)
- Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
- Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative)
Sites / Locations
- Aurora Health Care, St. Luke's Medical Center
Arms of the Study
Arm 1
Arm 2
Other
Other
Hybrid Ablation-cryoballoon alone
Hybrid ablation-cryoballoon plus RF
This group receives the hybrid surgical ablation (epicardial-endocardial ablation) with epicardial ablation and endocardial ablation consisting of pulmonary vein isolation with no further catheter ablation. This will be achieved using the nContact and Medtronic cryoballoon
This group receives the hybrid surgical ablation (epicardial-endocardial ablation) with epicardial ablation and endocardial ablation. Endocardial portion consists of pulmonary vein isolation using the cryoballoon with further catheter ablation, which may consist of ablation of complex fractionated electrograms and linear lesions. This will be achieved using the nContact and Medtronic Cryoballoon plus Thermocool Catheter.