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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT01636518
Eligibility Criteria:
Inclusion Criteria:
* Documented effectiveness failure of at least one Vaughan-Williams Class III AAD
* Persistent AF as defined by the HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation
* Absence of significant structural heart disease as demonstrated by a transthoracic echocardiogram (TTE) of all four chambers of the heart, computed tomography (CT) scan or magnetic resonance imaging (MRI) scan within 6 months prior to enrollment
* Absence of left atrial thrombus as documented by an imaging study (e.g., TTE, transesophageal echocardiogram (TEE), thoracic CT scan, MRI, or left atrial angiography) within 30 days prior to procedure
Exclusion Criteria:
* History of longstanding persistent AF for more than 3 years
* Documented left atrial size of 60 mm or more
* Documented left ventricular ejection fraction (LVEF) less than 40%
* History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
* Significant underlying structural heart disease requiring surgical or procedural intervention within the last six months of initial procedure
* Known contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
* Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis, etc.)
* Pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;
* Concomitant procedure planned
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01636518
Study Brief:
Protocol Section:
NCT01636518