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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013345
• Other study ID #: Coopertaive-PFA
• Status: Recruiting
• Phase: Phase 3
• Start date: October 25, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: November 2023
• Source: Charles University, Czech Republic
• Contact: Marek Hozman, MD
• Phone: +420 267 161 111
• Email: marek.hozman[@]fnkv.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: February 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Remimazolam
analgosedation without secured airway
• Propofol
analgosedation with secured airway
• Propofol
TIVA with secured airway

Locations

Country	Name	City	State
Czechia	University Hospital Kralovske Vinohrady	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary composite endpoint (rate of hypoxaemia, hypotension, or hypertension events)	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	Procedure duration
Secondary	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		Procedure duration
Secondary	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)		Procedure duration
Secondary	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)		Procedure duration
Secondary	Total procedural time		Procedure duration
Secondary	Analgosedation depth by bispectral (BIS) monitoring: area under the curve of BIS index (measured every 3 minutes during the procedure)		Procedure duration
Secondary	Procedural sedation quality	PROcedural Sedation Assessment Survey - a previously validated form	12-24 hours after the procedure
Secondary	Difficult sedation score	1-10 scale (10 = the worst), reported by an anaesthesiologist	Procedure duration
Secondary	Operator's satisfaction score	1-10 scale (10 = the worst), reported by the operating physician	Procedure duration
Secondary	Total number of serious adverse events	death, cardiopulmonary resuscitation (chest compression or adrenaline administration), an emergency intubation or prolonged stay in intensive care unit	From randomization until discharge
Secondary	carbon dioxide partial pressure after the procedure	partial pressure (kPa) of CO2 measured in an arterial blood sample	blood sample taken after the procedure (up to 10 minutes)
Secondary	28-day serious adverese events	death, a condition related to the procedure requiring inpatient hospitalization	discharge to the day 28