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Multicenter randomized clinical trial to evaluate two different amiodarone regimens to maintain sinus rhythm after cardioversion in persistent atrial fibrillation (PERIVERSION-2).
EU CTIS ID: 2024-514113-35-01
What this study is testing
To compare the efficacy in maintaining sinus rhythm 12 months post electrical cardioversion between standard (200 mg/d) and reduced (100 mg/d) doses of amiodarone in patients with persistent atrial fibrillation.
- 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
- Patients aged ≥ 18 ye
- Documented persistent atrial fibrillation (≥ 7 days in duration)
- Electively referred for Electrical Cardioversion under amiodarone treatment
- Signed informed consent
You likely can't join if
- Urgent electrical cardioversion
- Significant left ventricular hypertrophy (wall thickness ≥ 15mm)
- Hyperthyroidism or hypothyroidism
- Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST > 3 x upper limit of normal (ULN)
- Allergy, intolerance, or known hypersensitivity to study medications
- Patients with contraindications to amiodarone, such as uncontrolled thyroid dysfunction, severe sinus bradycardia, second- or third-degree AV block without a pacemaker, and a history of amiodarone-induced pulmonary toxicity.
See the full eligibility criteria
- Patients aged ≥ 18 ye
- Documented persistent atrial fibrillation (≥ 7 days in duration)
- Electively referred for Electrical Cardioversion under amiodarone treatment
- Signed informed consent
- Urgent electrical cardioversion
- Significant left ventricular hypertrophy (wall thickness ≥ 15mm)
- Hyperthyroidism or hypothyroidism
- Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST > 3 x upper limit of normal (ULN)
- Allergy, intolerance, or known hypersensitivity to study medications
- Patients with contraindications to amiodarone, such as uncontrolled thyroid dysfunction, severe sinus bradycardia, second- or third-degree AV block without a pacemaker, and a history of amiodarone-induced pulmonary toxicity.
- Women of childbearing potential unwilling to use contraceptive measures and breastfeeding women.
- Participation in another clinical trial involving investigational drugs
- Life expectancy less than 12 months
- Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.
- Atrial fibrillation post-cardiac surgery
- Previous myocardial infarction
- New York Heart Association (NYHA) Class IV heart failure
- Left ventricular ejection fraction (LVEF) <45%
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, 18-64 years, 65+ 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.