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

NCT07734194 | Recruiting

• 1 other identifier: ReFeR-PFA
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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).

  during the procedure

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with indication for AF ablation

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

University Hospital Kralovske Vinohrady

Prague, 100000, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marek Hozman, MD, PhD

CONTACT

+420267 161 111; marek.hozman@fnkv.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: January 1, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)