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Optimizing Postoperative Betablockade with Landiolol on top of oral betablocker to prevent New-Onset Atrial Fibrillation Following Cardiac Surgery in Caucasian patients: A multicenter, randomized, double-blind study.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524518-26-03
Enrollment
400
Registered
2026-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient scheduled for elective cardiac surgery using cardiopulmonary bypass, treated with landiolol for the prevention of postoperative atrial fibrillation.

Brief summary

First episode of postoperative atrial fibrillation occurring within the 7 postoperative days. Postoperative atrial fibrillation is defined as the de novo onset of postoperative atrial fibrillation, lasting more than 5 minutes and diagnosed on the electrocardiographic tracing from continuous intensive care unit monitoring (bedside monitor) and/or on the review of the 7-day Holter recording.

Detailed description

Occurrence of postoperative atrial fibrillation during the hospital stay up to 30 days following cardiac surgery, Time from ICU admission to the first episode of atrial fibrillation, Heart rate recorded hourly during the 72 hours following cardiac surgery, Blood pressure recorded hourly during the 72 hours following cardiac surgery, Proportion of time during which heart rate (HR) is controlled (60 ≤ HR < 80 bpm) within the 72 hours following cardiac surgery, Time from ICU admission to the first recurrence of atrial fibrillation, Length of ICU stay, Length of hospital stay, Serious adverse events: Severe bradycardia / Severe hypotension/ Ventricular tachycardia or ventricular fibrillation requiring specific treatment /Atrioventricular block requiring cardiac pacing/TIA or stroke Myocardial infarction /Cardiogenic Shock/Cardiac arrest/Renal failure requiring dialysis/ all-cause mortality

Interventions

Sponsors

GCS Ramsay Sante Enseignement Et Recherche
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
First episode of postoperative atrial fibrillation occurring within the 7 postoperative days. Postoperative atrial fibrillation is defined as the de novo onset of postoperative atrial fibrillation, lasting more than 5 minutes and diagnosed on the electrocardiographic tracing from continuous intensive care unit monitoring (bedside monitor) and/or on the review of the 7-day Holter recording.—

Secondary

MeasureTime frame
Occurrence of postoperative atrial fibrillation during the hospital stay up to 30 days following cardiac surgery, Time from ICU admission to the first episode of atrial fibrillation, Heart rate recorded hourly during the 72 hours following cardiac surgery, Blood pressure recorded hourly during the 72 hours following cardiac surgery, Proportion of time during which heart rate (HR) is controlled (60 ≤ HR < 80 bpm) within the 72 hours following cardiac surgery, Time from ICU admission to the first recurrence of atrial fibrillation, Length of ICU stay, Length of hospital stay, Serious adverse events: Severe bradycardia / Severe hypotension/ Ventricular tachycardia or ventricular fibrillation requiring specific treatment /Atrioventricular block requiring cardiac pacing/TIA or stroke Myocardial infarction /Cardiogenic Shock/Cardiac arrest/Renal failure requiring dialysis/ all-cause mortality—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 17, 2026