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 @ 12:45 PM
Ignite Modification Date:
2025-12-24 @ 12:45 PM
NCT ID:
NCT05366361
Eligibility Criteria:
Inclusion Criteria:
* referred for ablation or Maze surgery at Stanford Medicine for persistent AF (i.e. which requires cardioversion to terminate and/or lasts \>7 days)
* Per our clinical practice and guidelines (Calkins et al., Heart Rhythm 2018), patients will have failed or be intolerant of \>or= 1 anti-arrhythmic drug. Patients after Maze surgery typically have failed prior endocardial ablation.
Exclusion Criteria:
* active coronary ischemia or decompensated heart failure
* atrial or ventricular clot on trans-esophageal echocardiography
* pregnancy (to minimize fluoroscopic exposure)
* inability or unwillingness to provide informed consent
* rheumatic valve disease (results in a unique AF phenotype)
* thrombotic disease or venous filters
* prior chest surgery is a relative contraindication for Maze surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
80 Years
Study:
NCT05366361
Study Brief:
Protocol Section:
NCT05366361