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:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT01627106
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic AF (duration of current episode is ≤7 days), which is hemodynamically stable, and participant has no other condition at the time of screening that may result in acute hospitalization
* If female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up.
* Weigh at least 45 kg
* Receiving adequate anticoagulant therapy
Exclusion Criteria:
* Hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine
* Severe aortic stenosis
* Systolic blood pressure \<100 mmHg
* New York Heart Association (NYHA) Class III or IV heart failure
* Severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker
* Use of IV rhythm control anti-arrhythmics (Class I and III) within 4 hours of study drug administration
* Acute coronary syndrome (including myocardial infarction) within previous 30 days
* History of thyroid dysfunction
* Severe acute respiratory failure or cardiovascular collapse
* Participating in another drug study or has received an investigational drug within 30 days prior to enrollment
* Pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01627106
Study Brief:
Protocol Section:
NCT01627106