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Recruiting NCT07734194

Remimazolam-Fentanyl Mild Conscious Sedation Regimen in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation

Conditions: Atrial Fibrillation (AF)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 20
Sponsor: Charles University, Czech Republic

Location: University Hospital Kralovske Vinohrady Prague

Summary

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07734194). StuddyBuddy aggregates publicly available trial information.