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:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT00703157
Eligibility Criteria:
Inclusion Criteria:
* Patient has documented Paroxysmal AF as defined by the ACC/AHA/ESC guidelines
* Minimal one documented AF episode in the last 6 months
* Refractory to minimal two Class I or III anti-arrhythmic drug
* Age \> 18 years
* Signed and dated the Patient Informed Consent.
* Patient can tolerate anti-coagulation therapy (Warfarin/Coumadin)
Exclusion Criteria:
* Patient has a structural heart disease
* Ejection fraction \< 40 %
* Echocardiographic evidence for a left atrium \> 45 mm (parasternal axis)
* Patients on amiodarone, or patients known to be intolerant for amiodarone
* Dextrocardia, current endocarditis, systemic infection, renal failure
* Patient has known cerebrovascular disease, including a history of stroke, CVA or TIA
* Pregnancy at enrolment; or planned pregnancy within the follow up period
* Patient has a life expectancy less than 1 year
* The subject is participating in another device or drug study
* The patient is unable and/or unwilling to cooperate with study procedures or required follow up visits
* Echocardiographic (TTE) evidence for presence of left atrial thrombus
* Previous (cardio-) thoracic surgery
* Previous left atrial ablation
* Patients with permanent or persistent AF
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00703157
Study Brief:
Protocol Section:
NCT00703157