Remimazolam-Fentanyl Mild Conscious Sedation Regimen in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation | NCT07734194

NCT07734194

Overview

NCT ID: NCT07734194
Lead Sponsor: Charles University, Czech RepublicOTHER
Official Title: Remimazolam-Fentanyl Mild Conscious Sedation Regimen in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Brief 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.
Conditions: Atrial Fibrillation (AF)
Interventions: No data available

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Jan 1, 2026Actual
Primary Completion Date: Aug 1, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 20Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Marek Hozman, MD, PhDContact
marek.hozman@fnkv.cz+420267 161 111

Similar Studies

Participant Group/Arms

Cohort 1

Sedation will be carried by remimazolam (Paion Pharma, Aachen, Germany), and bolus doses of fentanyl will be used as an analgesic agent. At the beginning of the anesthesiologic procedures, the patients will receive an intravenous dose of 50 µg fentanyl followed by a bolus dose of remimazolam 5 mg (patients younger than 65 years with a weight over 50 kg), or remimazolam 2.5-5 mg (patients with age \> 65 years or ASA classification III-IV). The sedation will continue by intravenous infusion of remimazolam 0.5 mg/kg/h. Before the start of pulses, sedation/analgesia will be strengthened by bolus application of remimazolam 1,25-2.5 mg, and fentanyl 50-100 ug, respectively. At the same time, magnesium sulphate 1 g will be applied by a slow infusion. Additional doses of remimazolam/fentanyl could be administered and recorded in study protocols.