CompletedPhase 3Other

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

NCT ID

NCT06013345

Target Enrollment

127 participants

Start Date

2023-10-25

Est. Completion

2024-12-01

About This Study

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.

Conditions Studied

Atrial Fibrillation

Interventions

•Remimazolam
•Propofol
•Propofol

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full eligibility 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)

Study Locations (1)

University Hospital Kralovske Vinohrady

Prague, Czechia, Czechia