Chronic atrial fibrillation
Conditions
Sponsors
TOA EIYO LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with chronic (persistent or permanent) atrial fibrillation. (2) Resting heart rate: >=80 bpm (3) Outpatients
Exclusion criteria
Exclusion criteria: (1) Patients with any of the following findings related to heart disease. 1) Acute coronary syndrome, coronary revascularization or variant angina within 6 months prior to informed consent. 2) Cardioversion or catheter ablation within 3 months prior to informed consent. 3) Heart rate control with a pacemaker, etc. 4) Severe arrhythmia, cardiogenic shock, heart failure, cardiomyopathy, myocarditis or reduced cardiac function, or aortic or mitral valve stenosis or regurgitation at a moderate level or higher. (2) Patients with a history of a cerebrovascular event (except an asymptomatic cerebrovascular event). (3) Systolic blood pressure < 110 mmHg. (4) Patients with a disease for which anticoagulant therapy is contraindicated. (5) Patients with poor skin condition at the patch application site or history of dermatitis caused by a topical agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The change of mean heart rate as determined by 24 hours holter electrocardiogram. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy (1) Diurnal variation in heart rate as determined by 24 hours holter electrocardiogram. Resting heart rate Achievement rate to the target heart rate level. (2) Adverse events and adverse drug reactions. | — |
Countries
Japan
Outcome results
None listed