NCT06013345CompletedPhase 3
COnventional Vs. Optimised PERiprocedural Analgosedation Vs. Total IntraVEnous Anaesthesia for Pulsed-Field Ablation (COOPERATIVE-PFA)
Conventional Vs. Optimised Periprocedural Analgosedation Vs. Total Intravenous Anaesthesia for Pulsed-field Ablation: a Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 127 (actual)
- First submitted
- 17 Aug 2023
- Start date
- 25 Oct 2023
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Charles University, Czech Republic
- Diseases
- Atrial fibrillation
- NCT number
- NCT06013345
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 127
- From 25 Oct 2023 to the primary completion date, 30 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Obstructive sleep apnoea syndrome (AHI \>30)
- 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
- Epilepsy
Lab values
- Heart failure (NYHA III-IV), irrespective of left ventricular ejection fraction
- Left ventricular ejection fraction \< 20%
Other
- Significant valvulopathy (moderate or severe aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, moderate and severe mitral stenosis, severe tricuspid regurgitation)
- Low oxygen saturation (\<93%) at baseline
- Anticipated difficult airways
- ASA (American Society of Anaesthesiologists) score \> 4
- Schizophrenia
- Other individual contraindications (will be reported in detail)
Who the study is looking for
- Atrial fibrillation (AF) (paroxysmal, persistent or long standing persistent) with indication for catheter ablation
- Age above 18 years
- Capacity to give informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.