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

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.

Timeline

Start

2023-10-25

Primary completion

2024-09-30

Completion

2024-12-01

Outcome

Met primary endpoint

paper The primary end point occurred in 85.7% of P patients, 27.9% of R patients, and 66.7% of TIVA patients (P<0.001) PMID 40287932 ↗

paper remimazolam-ketamine DAS was superior to propofol-opioid regimens (either boluses or continuous) PMID 40287932 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Propofol	Small molecule	3 ug/ml	—
Comparator	Propofol	Small molecule	5 ug/ml	—
Comparator	Propofol	Small molecule	0.5 mg/kg	—
Subject	Remimazolam	Small molecule	0.5 mg/kg	—

Indications