Remimazolam-Fentanyl Mild Conscious Sedation Regimen in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation (ReFeR-PFA)

July 24, 2026 updated by: Charles University, Czech Republic
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Prague, Czechia, 100000
        • Recruiting
        • University Hospital Královské Vinohrady
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with indication for AF ablation

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint 1
Time Frame: during the procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 24, 2026

First Submitted That Met QC Criteria

July 24, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReFeR-PFA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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