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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT06922695
Eligibility Criteria:
Inclusion Criteria:
1. Participant is willing and able to give informed consent for participation in the trial.
2. Understand the risk and willing to discontinue oral anticoagulation (OAC).
3. Any gender aged 18 years or above.
4. Non-valvular paroxysmal atrial or persistent atrial fibrillation (AF) with a current rhythm control strategy. Paroxysmal patients must have \< 3 documented or symptomatic episodes of \>1 hour duration in the previous 3 months. Persistent patients must have been in continuous sinus rhythm for at least 4 weeks prior to enrolment.
5. CHA2DS2-VASc score between 1 and 3 in men and between 2 and 4 in women.
6. Able to take direct-acting oral anticoagulant (DOAC) in guideline recommended doses.
7. Left atrial (LA) diameter on echocardiogram less than 5 cm (anteroposterior dimensions) or LA volume less than 48 ml/m2.
Exclusion Criteria:
1. Any contraindication to OAC therapy with a DOAC in guideline recommended doses.
2. Mechanical heart valve prosthesis or moderate-to-severe mitral valve stenosis.
3. Permanent atrial fibrillation.
4. Hypertrophic cardiomyopathy.
5. Documented previous thromboembolic event (stroke, transient ischaemic attack or systemic embolism).
6. Spontaneous echo contrast observed in any imaging modality.
7. History of intracardiac thrombi.
8. History of congenital heart disease.
9. Severe chronic renal disease (eGFR \<15 ml/m) or on renal replacement therapy.
10. Pregnant or planning pregnancy.
11. Indication for OAC other than atrial fibrillation.
12. Inability to comply with protocol.
13. Smartphone with operating system (OS) not compatible with MyCareLink Heart app.
14. Contraindication for implantable cardiac monitor.
15. Visual or physical impairment that prevents ability to read and acknowledge smartphone/watch notifications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06922695
Study Brief:
Protocol Section:
NCT06922695