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

Last updated: January 30, 2025
Sponsor: Charles University, Czech Republic
Overall Status: Completed

Phase

3

Condition

Chest Pain

Arrhythmia

Cardiac Disease

Treatment

Remimazolam

Propofol

Clinical Study ID

NCT06013345
Coopertaive-PFA
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Age above 18 years

  • Capacity to give informed consent

Exclusion

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 mitralregurgitation, 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 chronicpharmacotherapy)

  • 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 Design

Total Participants: 127
Treatment Group(s): 2
Primary Treatment: Remimazolam
Phase: 3
Study Start date:
October 25, 2023
Estimated Completion Date:
December 01, 2024

Connect with a study center

  • University Hospital Kralovske Vinohrady

    Prague, 10034
    Czechia

    Site Not Available

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