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 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07441759
Eligibility Criteria:
Inclusion Criteria (PREFATE study): assessed at baseline
* Adults aged 65-95 years without prior AF and at High risk of AF, according to the risk score validated in the AFRICAT (Atrial Fibrilation Research in CATalonia) study. This scale considers the following variables for risk calculation: sex, age, weight, cardiac rate and CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 (doubled), diabetes mellitus, prior stroke or transient ischemic attack (doubled), vascular disease, age 65-74, female) score.
* with active records in the HCC3/CMBD systems
* CHA2DS2-VASc score≥2.
* Ability to use a smart phone (or at least the caregiver).
Exclusion Criteria: Patients with the following conditions will be excluded (exclusion criteria):
* Previous diagnosis of AF.
* Previous diagnosis of stroke.
* Severe cognitive impairment, with a score on the Global Deterioration Scale (GDS)≥3.
* Severe functional impairment, with a Barthel score ≤60, or modified Rankin score≥4.
* Active anticoagulant treatment at the inclusion.
* Vital prognosis less than 1 year.
* Pacemaker carriers.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
95 Years
Study:
NCT07441759
Study Brief:
Protocol Section:
NCT07441759