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:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT01047566
Eligibility Criteria:
Inclusion Criteria:
* Persistent AF with HR \>80 bpm at rest despite treatment with ≤ 2 rate control agents (i.e. beta blocker and/or calcium antagonist - Patients using digoxin are eligible)
* Documented AF in the past 24 hours
* Treated with the following rate control medication:
* beta blocker or
* calcium antagonist or
* beta blocker plus calcium antagonist or
* beta blocker plus digoxin or
* calcium antagonist plus digoxin
* Anticoagulant treatment in line with local guidelines
Exclusion Criteria:
* Incapacitated patients
* Paroxysmal or permanent AF
* Use of class I or III anti-arrhythmic drugs in the past 12 weeks
* Scheduled cardioversion or pulmonary vein ablation
* Unstable New York Heart Association (NYHA) class III and all class IV Heart Failure
* AV block grade 2 or 3
* Known severe renal impairment (serum creatinine \> 180 μmol/l)
* Known severe hepatic impairment (AST, ALT \> 3 x Upper Limit of Normal (ULN))
* Contra-indication for dronedarone
* Participation in a clinical drug study in the 3 months prior to inclusion
* Women of childbearing potential, who do not use adequate contraception
* Lactating women
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
46 Years
Study:
NCT01047566
Study Brief:
Protocol Section:
NCT01047566