Remimazolam-Fentanyl Mild Conscious Sedation Regimen in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Recruiting · NCT07734194 · Observational (researchers observe without assigning treatment) · Lead sponsor: Charles University, Czech Republic
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age above 18y Paroxysmal or persistent AF written agreement with inclusion to the study
Exclusion criteria
- 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
Where it is running
1 location listed.
- University Hospital Kralovske Vinohrady - Prague, Czechia