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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00519194
Eligibility Criteria:
Inclusion Criteria:
* 18-80 years old
* Permanent AF defined as continuous AF lasting \> one year OR non self-terminating AF lasting \> seven days but no more than one year with at least one failed DC cardioversion
* Have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (PFO) closure or coronary artery bypass surgery
* Be able to take anticoagulation therapy
* Be able to fulfill study requirements
* Be able to sign study-specific informed consent
Exclusion Criteria:
* Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy
* Prior cardiac surgery
* Presence of active endocarditis, local or system infection
* Presence of advanced heart failure (NYHA class \> II, \& LVEF \< 20%)
* Intraaortic balloon pump, IV inotropes or vasoactive agents within 30 days
* Emergent cardiac surgery due to acute MI or acute mitral regurgitation
* Life expectancy \< 1 year
* Major or progressive non-cardiac disease
* Presence of left atrial thrombi
* Left atrial diameter \> 6.0 cm
* Any condition that prevents investigator from safely performing procedure
* Positive urine or serum pregnancy test
* Prior left atrial ablation
* Currently participating in another clinical research study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00519194
Study Brief:
Protocol Section:
NCT00519194