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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT01174160
Eligibility Criteria:
Inclusion Criteria:
* Abstinent or willing to use 2 acceptable methods of birth control
* Patient has an atrial arrhythmia with dysrhythmic symptoms
* Patient is receiving adequate anticoagulant therapy
* Patient has stable blood pressure
* Patient weighs between 45 and 136 kg (99 and 300 lbs)
* Patient is adequately hydrated
Exclusion Criteria:
* Patient is pregnant, breast-feeding, or expecting to become pregnant during the study
* Patient routinely consumes more than 2 alcoholic drinks per day
* Patient has known or suspected prolonged QT, familial long QT syndrome, previous Torsades de Pointes, Brugada syndrome
* Patient has known bradycardia, advanced AV block, or sick-sinus syndrome, unless controlled by a pacemaker
* Patient has severe aortic stenosis
* Patient has atrial flutter
* Patient has Class IV congestive heart failure (CHF)
* Patient has had a myocardial infarction (MI) or acute coronary syndrome (ACS)
* Patient has had cardiac surgery within 30 days
* Patient has known atrial thrombus
* Patient has reversible causes of Atrial Fibrillation
* Patient has failed electrical cardioversion during current episode of Atrial Fibrillation
* Patient has uncorrected electrolyte imbalance
* Patient has clinical evidence of digoxin toxicity
* Patient has received certain antiarrhythmic drugs or intravenous amiodarone within 7 days
* Patient is known to be HIV positive
* Patient has a history of cancer within the past 5 years, except for certain skin or cervical cancers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01174160
Study Brief:
Protocol Section:
NCT01174160