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

Charles University, Czech Republic20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atrial Fibrillation (AF)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Kralovske Vinohrady

Prague, Czechia

RECRUITING

Outcomes

Primary Outcomes

Primary endpoint 1

The primary endpoint will be defined as the need for conversion to general anaesthesia or to deep analgesia (by adding another sedative agent).

Time frame: during the procedure

Central Contacts

Marek Hozman, MD, PhD

CONTACT

+420267 161 111 marek.hozman@fnkv.cz

Data from ClinicalTrials.gov

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