Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT02344394
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02344394
Study Brief:
Protocol Section:
NCT02344394