Mild Sedation with Remimazolam and Fentanyl During Pulsed-Field Ablation for Atrial Fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm study will assess the feasibility and safety of mild conscious sedation using remimazolam with fentanyl during FARAPULSE pulsed-field ablation for paroxysmal atrial fibrillation. Participants will be monitored carefully around the procedure to evaluate sedation-related safety outcomes and their experience of the procedure. The study does not specify a control group or intervention beyond the sedation regimen. Eligibility includes adults with AF who meet defined criteria, while several cardiac and airway conditions are exclusionary to minimize risk. The lead sponsor is Charles University in the Czech Republic, with the study conducted at University Hospital Královské Vinohrady in Prague.

Why it matters

Who can join: the full rules

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's running

• University Hospital Kralovske Vinohrady
  Prague, Czechia Recruiting

Study contacts

• Study coordinator: Marek Hozman, MD, PhD
• Email: marek.hozman@fnkv.cz
• Phone: +420267 161 111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.