Conventional vs. Optimised Periprocedural Analgosedation vs. Total Intravenous Anaesthesia for Pulsed-field Ablation: a Randomised Controlled Trial

Coopertaive-PFA

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.

2023-10-25

2024-10-01

2025-02-01

Recruiting

Early phase I

126

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study arms, analgosedation and TIVA protocols:\n\n1. Conventional propofol analgosedation (arm P): current standard practice in most centres, a combination of short-acting benzodiazepine (midazolam) at the beginning, short-acting opioid (sufentanil in this study) and propofol boluses before and during the application of ablation pulses with unsecured airway\n2. Optimised continuous intravenous analgosedation (arm R): ultrashort-acting benzodiazepine (remimazolam) and ketamine with unsecured airway\n3. Total intravenous anaesthesia with secured airway (arm TIVA): continuous propofol infusion using target controlled infusion (TCI) and short acting opioid boluses - sufentanil', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 126, 'type': 'ESTIMATED'}}

2023-11-28