Status:
COMPLETED
COnventional Vs. Optimised PERiprocedural Analgosedation Vs. Total IntraVEnous Anaesthesia for Pulsed-Field Ablation (COOPERATIVE-PFA)
Lead Sponsor:
Charles University, Czech Republic
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A prospective single blinded (subject blinded) 1:1:1 randomised control trial with three parallel arms testing superiority of analgosedation regimen based on remimazolam and total intravenous anesthes...
Eligibility Criteria
Inclusion
- Atrial fibrillation (AF) (paroxysmal, persistent or long standing persistent) with indication for catheter ablation
- Age above 18 years
- Capacity to give informed consent
Exclusion
- Heart failure (NYHA III-IV), irrespective of left ventricular ejection fraction
- Left ventricular ejection fraction \< 20%
- Significant valvulopathy (moderate or severe aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, moderate and severe mitral stenosis, severe tricuspid regurgitation)
- Obstructive sleep apnoea syndrome (AHI \>30)
- Low oxygen saturation (\<93%) at baseline
- High aspiration risk (hiatal hernia, gastroesophageal reflux disease on chronic pharmacotherapy)
- Hypersensitivity to the study drugs
- Chronic kidney disease (stage 4 and 5 of CKD), liver cirrhosis
- Anticipated difficult airways
- ASA (American Society of Anaesthesiologists) score \> 4
- Schizophrenia
- Epilepsy
- Other individual contraindications (will be reported in detail)
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT06013345
Start Date
October 25 2023
End Date
December 1 2024
Last Update
February 3 2025
Active Locations (1)
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1
University Hospital Kralovske Vinohrady
Prague, Czechia, Czechia, 10034