Clinical Trials

Inclusion Criteria:

• Written informed consent must be obtained before any assessment is performed.
• Male or female, age ≥ 18 years.
• AF with prior history of at least 2 episodes of AF, with at least 1 of the 2 AF episodes documented by 12-lead ECG, Holter, or any other method to record an ECG tracing within 6 months prior to the screening visit.
•  Normal Sinus Rhythm (NSR).
• Judged by the responsible physician to be on guideline directed stroke prevention.

Exclusion Criteria:

• Permanent AF at enrollment.
• Vaughan Williams class I or class III antiarrhythmic therapy within 7 days prior to enrollment, or amiodarone within 6 weeks prior to enrollment.
• Ongoing reversible cause of AF (e.g., hyperthyroidism, myocarditis, alcohol use, sepsisor infection-related AF, surgery-related AF, pulmonary embolism).
•  Implanted pacemakers, implanted cardioverter defibrillators, or implanted cardiac monitors (implantable loop recorders).
• Ablation for AF within 6 months prior to enrollment.
• Cardiac surgery within 6 months prior to enrollment.
• Heart failure with New York Heart Association class III/IV symptoms within 3 months prior to enrollment.
• Unstable angina, myocardial infarction, or coronary surgery within 3 months; or coronary angioplasty within 1 month prior to enrollment.
• Uncontrolled hypertension, defined as a documented systolic blood pressure ≥180 or diastolic blood pressure ≥ 110 mmHg on 2 separate dates within 3 months prior to enrollment.
• Stroke within 6 months prior to enrollment, or other neurologic or psychiatric condition which is likely to affect study compliance.
• 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).
• Knowledge of prior allergic reactions to adhesives or hydrogels

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 07/24/2024. Questions regarding updates should be directed to the study team contact.