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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT03509493
Eligibility Criteria:
Inclusion Criteria:
Group 1: Patients without structural heart disease
* Age 65 and older
* CHADSVASc score of 2 or more (including congestive heart failure, hypertension, age, diabetes, previous stroke, vascular disease and sex)
* Comorbidities such as: coronary artery disease, kidney insufficiency, sleep apnea or symptomatic complaints with negative Holter in the past
Group 2: Patients with structural heart disease
* Age 65 and older
* CHADSVASc score of 2 or more
* Left atrial volume indexed for body surface area (BSA) of 34 ml/m² or more, or left atrial diameter \> 5 cm
* And any of the following indicators:
* Diastolic dysfunction of at least grade 2 with restrictive filling (E/A 2 or more) or disturbed relaxation (E/A 0.8) and with E/e' septal 15 or more (E/e' lateral 10 or more) or tricuspid insufficiency (TI) of 2.8 m/s or more
* At least mitral insufficiency (grade 2/3 or 3/3) or mitral stenosis
* Hypertrophic (obstructive) cardiomyopathy
Group 3: Patients with high risk parameters for AF development
* Age 65 or more
* General Medical Record in the participating practice
* A 5-year risk of AF of at least 10% according to the CHARGE-AF risk score
Group 4: Patients post-cryptogenic stroke or TIA
\- Experienced a cryptogenic TIA or stroke in the past year since the start of the study
Group 5: Patients post-cardioversion therapy
* Confirmed AF patient based on 12-lead ECG
* Successful AF treatment using cardioversion (DCC or chemical) to convert the heart rhythm back to normal sinus rhythm
* Subjects are older than 18 years
Group 6: Patients post-ablation therapy
* Confirmed AF patient based on 12-lead ECG
* Successful AF treatment using ablation therapy to restore the heart rhythm back to sinus rhythm in the past 3 months
* Subjects are older than 18 years
Exclusion Criteria:
* Non-native Dutch
* Pacemaker dependent heart rhythm
* Perniosis patient
* Intense callus formation
* Low adherence to protocol
* Tremor or Parkinson
* Signs of Alzheimer or dementia
* No self-care ability
* Known AF patient
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03509493
Study Brief:
Protocol Section:
NCT03509493