Important: Models were tasked with extracting evidence from documents. Some outputs may be low quality and should be scored accordingly.
Your task: Compare the model-generated prediction (right panel) against the ground truth criteria (left panel).
Evaluation scale (0-4):
Consider both content accuracy and completeness. Some predictions may be technically "correct" but incomplete or out of order.
INCLUSION CRITERIA 1. Men or women aged more than 18 years (inclusive)Patients with current episode of persistent Atrial Fibrillation (AF) between 7 days and 6 months duration for whom electrical cardioversion is warrantedPrevious history of first documented episode of persistent AF. 2. Previous history of ischemic or non ischemic heart failureNew York Heart Association (NYHA) class I or II chronic heart failure at selection and at inclusionLeft ventricular systolic dysfunction defined at selection and at inclusion by a reduced left ventricular ejection fraction (LVEF) ≥ 30% and ≤ 45% or for patients with a LVEF > 45%:an increased left ventricular end-diastolic size (diameter ≥ 60 mm and/or > 32 mm/m² and/or volume > 97 ml/m²)and/or an increased left ventricular end-systolic size (diameter > 45 mm and/or > 25 mm/m² and/or volume > 43 ml/m²)and/or a reduced left ventricular outflow tract velocity time integral < 15 cmOn appropriate, stable medical treatments for heart failure, including a diuretic and/or angiotensin-converting enzyme, and/or angiotensin-receptor blocker and/or mineralocorticoid receptor (MR) antagonists, and/or betablockersLeft atrial area ≤ 40 cm² at selection and at inclusionPatients treated or having to be treated by vitamin K antagonistFor female patient of child-bearing potential:In all the countries except Italy:Use of an effective method of contraception (hormonal contraception or intra-uterine device) assessed by the investigator, for at least 2 months before the selection in the study, and agreement to go on using it during the whole duration of the study and up to 1 month after the last dose of the study treatmentDocumented as surgically sterilizedIn Italy only:Absolute abstention from sexual intercourse during the whole duration of the study and for a month after the end of the study orUse of double barrier contraception method (use of effective medical contraception method) from at least 2 months before the start of the study to the entire duration of the study and for a month after the end of the study orDocumented as surgically sterilized. 3. For female patient of child-bearing potential: negative urine pregnancy test at inclusionFor male with a child-bearing potential partner (In Italy only):Absolute abstention from sexual intercourse during the whole duration of the study and for 3 months after the end of the study orUse of double barrier contraception method (use of condom for male and effective contraception method for the partner) from the entire duration of the study to 3 months after the end of the study. 4. Ethical / legal considerations:Having signed his/her written informed consent,Affiliated to a social security system, or is beneficiary (if applicable in the national regulation) EXCLUSION CRITERIA 1. No previous history of first documented episode of persistent AFMore than two successful cardioversions (electrical or pharmacological) in the last 6 months 2. Secondary Atrial Fibrillation due to alcohol or severe valvular heart disease (grade III to IV)NYHA class III or IV heart failure at selection or at inclusion 3. Thyroid disease uncontrolled by treatment: TSH ± T4L ± T3L to be checked in case of treatment for thyroid disease 4. Myocardial infarction or unstable angina or presence of unstable ischemic coronaropathy assessed by coronarography or cardiac stress test (Echo stress, exercise stress test, nuclear or MR perfusion evaluation methods) within 6 months before selection 5. Severe chronic kidney disease (creatinine ≥ 25 mg/L or estimated glomerular filtration rate < 30 ml/min) at selection 6. Bradycardia (HR ≤ 50 bpm) 7. Hyperkalemia or hypokalemia (according to the standards of local laboratories) at selection 8. Cardiac surgery within 3 months before selection or planned during the study duration 9. Criteria related to treatments:Previously ineffective pharmacological or electrical cardioversion 10. Concomitant treatment with ranolazine or any antiarrhythmic drug (within 7 days prior to selection), except amiodarone, dronedarone and stable dose of digoxin, betablockers, calcium-blockers 11. Concomitant treatment with oral amiodarone or dronedarone from selection 12. Concomitant treatment with intravenous amiodarone from selection 13. Patient requiring a cardiac resynchronization therapy (CRT) or having undergone CRT implantation within the last 6 months 14. Treatment with any Polyunsaturated Fatty Acid (PUFA) within the last 3 months 15. Dietary supplement with ω 3 or ω 6 according to investigator's judgement 16. Having undergone any form of ablation therapy for AFPatient treated with oral anticoagulant treatment other than vitamin K antagonist: new oral anticoagulants (dabigatran, rivaroxaban, apixaban), or treated with irreversible antiplatelet agents P2Y12 inhibitors such as ticlopidine, clopidogrel or prasugrel 17. Other criteria:Patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion 18. Patient having taken part in a clinical trial in the preceding 2 months or taking part in a trial at the time of selection 19. Patient linguistically or mentally unable to understand the nature, objectives and possible consequences of the trial, or refusing to patient himself/herself to its constraints 20. Patient family member or work associate (secretary, nurse, technician,..) of the Investigator 21. Patient having forfeited his / her freedom by administrative or legal award or being under guardianship 22. Breastfeeding female patient
), • and/or a reduced left ventricular outflow tract velocity time integral 45%: • an increased left ventricular end-diastolic size (diameter ≥ 60 mm and/or > 32 mm/m² and/or volume > 97 ml/m²) • and/or an increased left ventricular end-systolic size (diameter > 45 mm and/or > 25 mm/m² and/or volume > 43 ml/m²) • and/or a reduced left ventricular outflow tract velocity time integral 3 the advocated actions are: Final version 1076/1185 − No transesophageal echocardiography before cardioversion − For asymptomatic patients: - 3 150 µmol/l whatever the baseline value • If missing baseline : value > 150 µmol/l LIVER FUNCTION TESTS ALAT If normal baseline : •ALAT > 2 N If abnormal baseline : →if baseline value ≤ 2.5 N : • increase of at least 100 % as compared to baseline value → if baseline value > 2.5 N : • value > 5 N and/or ASAT If normal baseline : • ASAT > 2 N If abnormal baseline : → if baseline value ≤ 2.5 N : • increase of at least 100 % as compared to baseline value → if baseline value > 2.5 N : • value > 5 N and/or Alkaline phosphatase (AP) If normal baseline : • AP > 1.25 N If abnormal baseline : • AP > 2 N and/or Total bilirubin (TB) ﷃ� If normal baseline : • TB > 1.5 N ﷃ� If abnormal baseline : • TB > 2 N N=upper limit of normal range International consensus Meeting. International Journal of Clinical Pharmacology, Therapy and Toxicology, 1990;28:317-322 Standardisation of definitions and criteria of causality assessment of adverse drug reactions: drugs-induced liver disorders: report of an Standardisation of definitions and criteria of causality assessment of adverse drug reactions: drugs-induced cytopenia. International Journal of Clinical Pharmacology, Therapy and Toxicology, 1991;29:75-81 Final version 1100/1185 Cardiovascular Safety Table 1: Predefined Limits for Potentially Clinically Significant Changes (PSC) and PSC Leading to Clinically Significant Values (PSCV) Parameter PSC PSCV SBP Increase ≥ 20 mmHg Decrease ≥ 20 mmHg SBP ≥ 160 mmHg and increase ≥ 20 mmHg SBP ≤ 90 mmHg and decrease ≥ 20 mmHg DBP Increase ≥ 10 mmHg Decrease ≥ 10 mmHg DBP ≥ 100 mmHg and increase ≥ 10 mmHg DBP ≤ 50 mmHg and decrease ≥ 10 mmHg HR Increase ≥ 10 bpm Decrease ≥ 10 bpm HR ≥ 110 bpm and increase ≥ 10 bpm HR ≤ 50 bpm and decrease ≥ 10 bpm Table 2: Predefined Classes for changes from Baseline to the Maximum (and/ or Minimum) Post-baseline Value Classes of Change from Baseline to the Maximum Post-baseline Value Classes of Change from Baseline to the Minimum Post-baseline Value SBP mmHg DBP mmHg HR bpm SBP mmHg DBP mmHg HR bpm All All All All All All ≥ 0 ≥ 0 ≥ 0 ≤ 0 ≤ 0 ≤ 0 > 0 > 0 > 0 90 and DBP > 50 SBP [140;160[ and DBP 45%: • an increased left ventricular end-diastolic size (diameter ≥ 60 mm and/or > 32 mm/m² and/or volume > 97 ml/m²) • and/or an increased left ventricular end-systolic size (diameter > 45 mm and/or > 25 mm/m² and/or volume > 43 ml/m²) • and/or a reduced left ventricular outflow tract velocity time integral 1/100, 1/1000, 1/10000, 45%: • an increased left ventricular end-diastolic size (diameter ≥ 60 mm and/or > 32 mm/m² and/or volume > 97 ml/m²), • and/or an increased left ventricular end-systolic size (diameter > 45 mm and/or > 25 mm/m² and/or volume > 43 ml/m²), • and/or a reduced left ventricular outflow tract velocity time integral 45%: • an increased left ventricular end-diastolic size (diameter ≥ 60 mm and/or > 32 mm/m² and/or volume > 97 ml/m²) • and/or an increased left ventricular end-systolic size (diameter > 45 mm and/or > 25 mm/m² and/or volume > 43 ml/m²) • and/or a reduced left ventricular outflow tract velocity time integral 3 the advocated actions are: Final version 1100/1185 − No transesophageal echocardiography before cardioversion − For asymptomatic patients: - 3 150 µmol/l whatever the baseline value • If missing baseline : value > 150 µmol/l LIVER FUNCTION TESTS ALAT If normal baseline : •ALAT > 2 N If abnormal baseline : →if baseline value ≤ 2.5 N : • increase of at least 100 % as compared to baseline value → if baseline value > 2.5 N : • value > 5 N and/or ASAT If normal baseline : • ASAT > 2 N If abnormal baseline : → if baseline value ≤ 2.5 N : • increase of at least 100 % as compared to baseline value → if baseline value > 2.5 N : • value > 5 N and/or Alkaline phosphatase (AP) If normal baseline : • AP > 1.25 N If abnormal baseline : • AP > 2 N and/or Total bilirubin (TB) ﷃ� If normal baseline : • TB > 1.5 N ﷃ� If abnormal baseline : • TB > 2 N N=upper limit of normal range International Journal of Clinical Pharmacology, Therapy and Toxicology, 1990;28:317-322 Standardisation of definitions and criteria of causality assessment of adverse drug reactions: drugs-induced liver disorders: report of an Standardisation of definitions and criteria of causality assessment of adverse drug reactions: drugs-induced cytopenia. International Journal of Clinical Pharmacology, Therapy and Toxicology, 1991;29:75-81 Final version 1130/1185 Cardiovascular Safety Table 1: Predefined Limits for Potentially Clinically Significant Changes (PSC) and PSC Leading to Clinically Significant Values (PSCV) Parameter PSC PSCV SBP Increase ≥ 20 mmHg Decrease ≥ 20 mmHg SBP ≥ 160 mmHg and increase ≥ 20 mmHg SBP ≤ 90 mmHg and decrease ≥ 20 mmHg DBP Increase ≥ 10 mmHg Decrease ≥ 10 mmHg DBP ≥ 100 mmHg and increase ≥ 10 mmHg DBP ≤ 50 mmHg and decrease ≥ 10 mmHg HR Increase ≥ 10 bpm Decrease ≥ 10 bpm HR ≥ 110 bpm and increase ≥ 10 bpm HR ≤ 50 bpm and decrease ≥ 10 bpm Table 2: Predefined Classes for changes from Baseline to the Maximum (and/ or Minimum) Post-baseline Value Classes of Change from Baseline to the Maximum Post-baseline Value Classes of Change from Baseline to the Minimum Post-baseline Value SBP mmHg DBP mmHg HR bpm SBP mmHg DBP mmHg HR bpm All All All All All All ≥ 0 ≥ 0 ≥ 0 ≤ 0 ≤ 0 ≤ 0 > 0 > 0 > 0 90 and DBP > 50 SBP [140;160[ and DBP 45%: • an increased left ventricular end-diastolic size (diameter ≥ 60 mm and/or > 32 mm/m² and/or volume > 97 ml/m²) • and/or an increased left ventricular end-systolic size (diameter > 45 mm and/or > 25 mm/m² and/or volume > 43 ml/m²) • and/or a reduced left ventricular outflow tract velocity time integral 1/100, 1/1000, 1/10000, 45%: • an increased left ventricular end-diastolic size (d