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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT01661205
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 year
* Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III antiarrhythmic drug (AAD).
* Patients with failed catheter ablation attempts are eligible if the patients are symptomatic with persistent or longstanding persistent AF. (catheter ablation procedure must be more than 3 months prior to index procedure)
* Life expectancy of at least two years
* Patient will and able to provide informed consent
* Patient is willing and able to attend the scheduled follow-up visits
Exclusion Criteria:
* Prior Cardiothoracic Surgery
* Patient has NYHA (New York Heart Association) Class IV heart failure
* Evidence of underlying structural heart disease requiring surgical treatment
* Surgical procedure within the 30 days prior to the index procedure
* 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
* Presence of thrombus in the left atrium determined by echocardiography
* History of blood dyscrasia
* Contraindication to anticoagulation, based on Investigator's opinion
* Mural thrombus or tumor
* Moderate to Severe COPD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01661205
Study Brief:
Protocol Section:
NCT01661205