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"Multicenter randomized clinical trial to evaluate the cardioverter capacity of amiodarone pre-electrical cardioversion in persistent atrial fibrillation"
EU CTIS ID: 2023-507201-34-00
What this study is testing
To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- INCLUSION CRITERIA: 1.Patients ≥18 years old. 2.Persistent atrial fibrillation (≥ 7 days duration). 3.Referred for elective electrical cardioversion. 4. Signing of the informed consent
You likely can't join if
- EXCLUSION CRITERIA: 1. Need of urgent electrical cardioversion 2.Mean Heart rate <50 bpm 3.Planned ablation < 1 month after ECV. 4.Treatment with anti-arrhythmic drugs (IC, III) the last 7 days previous to inclusion (in the case of amiodarone on the 30 days previous to inclusion) 5.Atrial fibrillation post-cardiac surgery 6.New York Heart Association (NYHA) Class IV heart failure 7.Left ventricular ejection fraction (LVEF) ≤30% 8.History of thyroid disease (hyperthyroidism or hypothyroidism) 9.Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST > 3 x upper limit of normal (ULN) 10.Allergy, intolerance, or known hypersensitivity to study medication 11.Women of childbearing potential unwilling to use contraceptive measures 12.Participation in another clinical trial involving investigational drugs 13.Life expectancy less than 12 months 14.Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.