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

NCT ID: NCT06013345

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2024-12-01

Brief 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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm P

Patients in arm P will be administered 2-3 mg midazolam IV before the beginning of the procedure, 5-10 mcg sufentanil IV and a loading dose of propofol 0,8-1,0 mg/kg in 2-5 minutes before the start of the ablation phase. During the procedure, boluses of 0,5 mg/kg propofol will be repeated as needed, in case of inappropriate analgosedation, boluses of midazolam and/or sufentanil can also 0be repeated.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

analgosedation with secured airway

Arm R

Patients in arm R will be administered 2,5 mg loading dose of remimazolam followed by continuous infusion at 0,5 mg/h/kg of ideal body weight (IBW, calculated using the Miller formula) and a dose of ketamine 1 mg/kg IBW 2-5 minutes before the beginning of the ablation phase. In case of inadequate sedation depth, a bolus of 2,5 mg remimazolam can be repeated as needed. If the patient shows signs of pain or discomfort, a single dose of ketamine - 0,5 mg/kg IBW - will be administered, followed by a bolus of 5-10 mcg sufentanil if needed. The continuous infusion will be terminated as the last ablation pulses are delivered.

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

analgosedation without secured airway

Arm TIVA (Total Intravenous Anesthesia)

Patients randomised in arm TIVA will be administered light analgosedation with spontaneous ventilation for the first part of the procedure. The analgosedation will be induced and maintained with bolus of 5 mcg sufentanil IV and propofol infusion dosed by TCI system (the target plasma concentration for propofol 1-2 mcg/ml). Before the beginning of the ablation phase, general anesthesia will be induced with one bolus of 5-10 mcg sufentanil (the TCI target 3-7 mcg/ml for induction and 3-5 mcg/ml for the rest of the procedure), and a bolus of rocuronium 0,2-0,4 mg/kg IBW. Then, the airways will be secured with a laryngeal mask (LMA), the patient ventilated (0,4 - 0,45 FiO2, the target EtCO2 30 - 45 mmHg). After the last ablation pulse is delivered, infusion of propofol will be ceased and LMA extracted at the return of consciousness, muscle strength and sufficient spontaneous ventilation. If residual muscle relaxation occurs, sugammadex will be administered.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

TIVA with secured airway

Interventions

Remimazolam

analgosedation without secured airway

Intervention Type: DRUG

Propofol

analgosedation with secured airway

Intervention Type: DRUG

Propofol

TIVA with secured airway

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Marek Hozman, MD, PhD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Kralovske Vinohrady

Prague, Czechia, Czechia

Countries

Czechia

References

Sochorova V, Kunstatova V, Osmancik P, Duska F, Herman D, Waldauf P, Poviser L, Karch J, Znojilova L, Filipcova V, Hozmanova J, Vesela J, Hozman M. COOPERATIVE-PFA: A Three-Arm Randomized Controlled Trial. Circulation. 2025 Jul 22;152(3):150-159. doi: 10.1161/CIRCULATIONAHA.125.074427. Epub 2025 Apr 27.

Reference Type: DERIVED

PMID: 40287932 (View on PubMed)

Other Identifiers

Coopertaive-PFA

Identifier Type: -

Identifier Source: org_study_id