Mild Sedation Method for Heart Rhythm Procedure in Atrial Fibrillation Patients
Tests a light sedation drug mix during heart rhythm treatment in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Remimazolam-Fentanyl Mild Conscious Sedation Regimen in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Key facts
- Where
- Prague, CzechiaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with paroxysmal or persistent atrial fibrillation who are having pulsed-field ablation and agree in writing to take part.
- Age
- Above 18 years
- Sex
- All sexes can join.
- Disease stage
- Paroxysmal or persistent atrial fibrillation (AF).
- Earlier treatment
- People taking benzodiazepine drugs (or other sedative drugs, at the anaesthesiologist's discretion) cannot join.
Main reasons for not taking part
- BMI above 35kg/m2
- Left ventricle ejection fraction (EF) below 40%
- Sleep apnoea (OSA) syndrome on therapy, or an expected difficult airway
- Severe COPD, severe pulmonary hypertension, or significant valve disease (3/4 or more)
- Symptomatic heart failure or myasthenia gravis
Read by machine on 9 November 2026.
Where in Czechia
- University Hospital Kralovske VinohradyPrague, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Charles University, Czech Republic
- Trial code
- NCT07734194
- Record updated
- 29 July 2026
- Original description
This prospective single-arm study will evaluate whether mild conscious sedation using remimazolam with fentanyl is a feasible alternative to deeper sedation or general anaesthesia during FARAPULSETM pulsed-field ablation for paroxysmal atrial fibrillation, with careful periprocedural monitoring and assessment of both sedation-related safety outcomes and patient-reported procedural experience.Read full original descriptionShow less
Remimazolam-Fentanyl Mild Conscious Sedation Regimen in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
This prospective single-arm study will evaluate whether mild conscious sedation using remimazolam with fentanyl is a feasible alternative to deeper sedation or general anaesthesia during FARAPULSETM pulsed-field ablation for paroxysmal atrial fibrillation, with careful periprocedural monitoring and assessment of both sedation-related safety outcomes and patient-reported procedural experience.
Inclusion: Age above 18y Paroxysmal or persistent AF written agreement with inclusion to the study.
Exclusion: BMI > 35kg/m2 EF of the left ventricle < 40% OSA syndrome on therapy anticipated difficult airway severe COPD significant valvulopathy (3/4 or more) symptomatic heart failure irrespective of ejection fraction severe pulmonary hypertension benzodiazepine drugs medication (or other sedative drugs at the discretion of the anesthesiologist) myasthenia gravis.