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NCT Number: NCT06013345

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Kralovske Vinohrady

Prague, Czechia, 10034

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Remimazolam

Drug

analgosedation without secured airway

Propofol

Drug

analgosedation with secured airway

Primary outcomes

  1. Primary composite endpoint (rate of hypoxaemia, hypotension, or hypertension events)

    Time frame: Procedure duration

    Composite endpoint consisting of the rate of (1) hypoxaemia events requiring intervention, (2) hypotension events requiring intervention or leading to the procedure interruption, or (3) hypertension events requiring intervention

Secondary outcomes

  1. Total number of haemodynamic instability events (hypoxemia, hypotension, hypertension; defined above), each five minutes of a continuous instability counts as a new event, as well as an instability persisting despite an intervention

    Time frame: Procedure duration

  2. Total number of: a) hypoxemia events hypoxaemia <85% (more than 60s) b) hypotension events = systolic blood pressure (SBP) < 85 mmHg (more than 60s) c) hypertension event = SBP > 200 mmHg (more than 60s)

    Time frame: Procedure duration

  3. Total number of interventions a) jaw thrust b) nasopharyngeal airway administration c) LMA / orotracheal intubation d) increasing FiO2 (oxygen flow) e) hypotensive drugs administration f) vasoactive drugs administration (ephedrine, noradrenaline)

    Time frame: Procedure duration

  4. Total procedural time

    Time frame: Procedure duration

  5. Analgosedation depth by bispectral (BIS) monitoring: area under the curve of BIS index (measured every 3 minutes during the procedure)

    Time frame: Procedure duration

  6. Procedural sedation quality

    Time frame: 12-24 hours after the procedure

    PROcedural Sedation Assessment Survey - a previously validated form

  7. Difficult sedation score

    Time frame: Procedure duration

    1-10 scale (10 = the worst), reported by an anaesthesiologist

  8. Operator's satisfaction score

    Time frame: Procedure duration

    1-10 scale (10 = the worst), reported by the operating physician

  9. Total number of serious adverse events

    Time frame: From randomization until discharge

    death, cardiopulmonary resuscitation (chest compression or adrenaline administration), an emergency intubation or prolonged stay in intensive care unit

  10. carbon dioxide partial pressure after the procedure

    Time frame: blood sample taken after the procedure (up to 10 minutes)

    partial pressure (kPa) of CO2 measured in an arterial blood sample

  11. 28-day serious adverese events

    Time frame: discharge to the day 28

    death, a condition related to the procedure requiring inpatient hospitalization

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2023
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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