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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07437456
Eligibility Criteria:
Retrospective Part The retrospective part will include patients who attended a physician consultation for atrial fibrillation three years ago and who met the inclusion criteria at that time.
Inclusion criteria for the retrospective part:
* Male or female patients aged 18 to 64 years at the time of data registration;
* Presence of a specialist-confirmed diagnosis of atrial fibrillation;
* CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women.
Non-inclusion criteria for the retrospective part:
* Age under 18 years;
* Age over 64 years;
* CHA₂DS₂-VASc score greater than 2 for men and greater than 3 for women;
* Inability to undergo screening examination and follow-up;
* Organ or tissue transplantation less than 5 years prior to study enrollment;
* Open heart surgery (coronary artery bypass grafting, valve replacement, reconstructive aortic surgery) within 6 months prior to study enrollment;
* Established diagnosis of dementia of any severity and/or established diagnosis of moderate or severe encephalopathy, as well as other conditions precluding independent regular medication intake.
Prospective Part
Inclusion criteria for the prospective part:
* Male or female patients aged 18 to 64 years at the time of data registration;
* Presence of a specialist-confirmed diagnosis of atrial fibrillation;
* CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women at the time of screening.
Non-inclusion criteria for the prospective part:
* Age under 18 years;
* Age over 64 years;
* CHA₂DS₂-VASc score greater than 2 for men and greater than 3 for women;
* Inability to undergo screening examination and follow-up;
* Organ or tissue transplantation less than 5 years prior to study enrollment;
* Open heart surgery (coronary artery bypass grafting, valve replacement, reconstructive aortic surgery) within 6 months prior to study enrollment;
* Established diagnosis of dementia of any severity and/or established diagnosis of moderate or severe encephalopathy, as well as other conditions precluding independent regular medication intake.
Exclusion criteria:
* Patient withdrawal of consent for further participation in the study;
* Identification of factors precluding further patient participation in the study (at the physician's discretion).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT07437456
Study Brief:
Protocol Section:
NCT07437456