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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT05381805
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older;
* Documented atrial fibrillation;
* Referred for any type of AF ablation: catheter ablation, stand-alone surgical AF ablation, surgical AF ablation concomitant with cardiac surgery, hybrid AF ablation, or redo AF ablation;
* Able and willing to provide written informed consent.
Exclusion Criteria:
* Conditions preventing the patient from adhering from the study protocol;
* Emergency procedures.
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG-imaging is asked:
* Severe allergic reaction against contrast agents used in the CT- or MRI-protocol
* Severe allergic reaction against body surface electrodes
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked:
• Status after esophageal or gastric surgery
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for Cardiovascular Magnetic Resonance (ISOLATION CMR) is asked:
• Contraindication to MRI
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for concomitant hybrid ablation of atrial fibrillation (COMBAT-AF) is asked:
• Prior catheter or surgical AF ablation.
Specific exclusion criteria for epicardial mapping (only applicable for patients undergoing hybrid or surgical AF ablation):
* Chronic obstructive pulmonary disease (COPD) Gold 11, 111, or IV;
* Heart failure, currently in New York Heart Association (NYHA) class Ill or IV;
* Any other pulmonary, cardiac, or other condition that may compromise a safe conduct of epicardial mapping in the opinion of the treating physician or investigator, taking the prolonged duration of single lung ventilation into account.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05381805
Study Brief:
Protocol Section:
NCT05381805