The goal of this study is to see if different mobile or wearable devices can track how long a person's heart is in atrial fibrillation over four months. Atrial fibrillation happens when the heart beats in an irregular way. The amount of time someone's heart is in atrial fibrillation can be different for each person and can change over time. Being able to measure how often this happens can help doctors find better treatments. In this study, we will test three mobile or wearable devices to see how well they measure heart rhythm over time.
In this study you will use the devices during a period of 4 months. Throughout the study, you will fill out a symptom diary whenever you experience symptoms that you feel are caused by atrial fibrillation. You will also be asked to complete several short questionnaires throughout the study. The devices used in this study are not experimental. We will perform several experimental analyses using the data gathered during the study to answer scientific questions related to atrial fibrillation.
1.You must sign a written consent form before any tests or exams are done. 2.You must be a man or woman who is 18 years or older. 3a. You must have had at least one episode of atrial fibrillation (AF) at age 50 or older, or at least two episodes of AF between ages 18 and 49 before the screening visit. 3b. You must have had an episode of AF within the last 12 months before the screening visit, proven by a 12-lead ECG, Holter monitor, or another approved heart rhythm recording, confirmed by the study doctor. 4a. You must have a normal heart rhythm (normal sinus rhythm) at the baseline visit. 5.Your doctor must confirm that you are receiving the recommended treatment to prevent stroke. Patient inclusion criteria Patients eligible for inclusion in this study must fulfill all the following criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male or female, age 18 years or older. 3a. History of at least 1 episode of AF occurring at age 50 years or older, or at least 2 episodes of AF between ages 18 to 49, prior to Screening Visit. 3b. Episode of AF within the last 12 months prior to the Screening Visit, documented by 12-lead ECG, Holter, or any other method to record an ECG tracing as attested by the investigator. 4a. Normal Sinus Rhythm (NSR) at Baseline Visit. 5. Judged by the responsible physician to be on guideline directed stroke prevention Patient exclusion criteria Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. Permanent AF at enrollment. 2. Exclusion Criteria removed from Protocol Amendment v02. 3. Ongoing reversible cause of AF (e.g., hyperthyroidism, myocarditis, alcohol use, sepsis or infection-related AF, surgery-related AF, pulmonary embolism). 4a. Implanted cardioverter defibrillators. 5a. At enrollment, previous ablation for AF without a recurrence of AF occurring two or more months after the procedure. 6. Cardiac surgery within 6 months prior to enrollment. 7a. Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening. 8. Unstable angina, myocardial infarction, or coronary surgery within 3 months; or coronary angioplasty within 1 month prior to enrollment. 9. Uncontrolled hypertension, defined as a documented systolic blood pressure greater than or equal to 180 or diastolic blood pressure greater than or equal to 110 mmHg on 2 separate dates within 3 months prior to enrollment. 10. Stroke within 6 months prior to enrollment, or other neurologic or psychiatric condition which is likely to affect study compliance. 11. A pattern or history of excessive alcohol use over the last 2 years prior to enrollment as evidenced by: > 21 units per week for males and > 14 units for females (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine). 12. Knowledge of prior allergic reactions to adhesives or hydrogels.
Protocol Number: 24-1245
Principal Investigator