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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01694394
Eligibility Criteria:
Inclusion Criteria
Patients will be eligible for inclusion if they meet both of the following:
1. Age ≥ 65, plus:
* CHA2DS2-VASc score ≥ 2 Or
* Obstructive sleep apnea (documented by polysomnography, ambulatory oximetry, positive Berlin Questionnaire or requiring the use of CPAP/BiPAP) Or
* BMI \> 30
2. Echocardiographic or biochemical evidence of increased risk of AF:
* Left atrial enlargement on a clinical echocardiography at any time prior to enrollment ( defined as LA volume ≥ 58 ml or LA diameter of ≥ 4.4 cm) Or
* Serum NT-ProBNP ≥ 290 pg/mL Exclusion Criteria
1\. Previously documented history of atrial fibrillation or atrial flutter 2. Current chronic treatment with oral anticoagulation (i.e. those on peri-operative prophylaxis would be eligible) 3. Patient with implanted pacemaker or defibrillator with an atrial lead 4. Definitive plan for cardiac surgery in the next 6 months (patients who are having coronary angiography with a possibility of cardiac surgery are still eligible)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01694394
Study Brief:
Protocol Section:
NCT01694394