COnventional vs. Optimised PERiprocedural Analgosedation vs. Total IntraVEnous Anaesthesia for Pulsed-Field Ablation (COOPERATIVE-PFA)

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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 anesthesia over propofol based analgosedation. The primary composite endpoint consists of hypoxaemia, hypotension, or hypertension requiring intervention.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charles University, Czech Republic
• Treatments: Propofol

Criteria

Inclusion Criteria:

• Atrial fibrillation (AF) (paroxysmal, persistent or long standing persistent) with indication for catheter ablation

• Age above 18 years

• Capacity to give informed consent

Exclusion Criteria:

• 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)