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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCharles University, Czech Republic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Patients with indication for AF ablation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20 Participants
are grouped into 1 trial group
Group A: Cohort 1

Trial outcomes

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).

Time frame
during the procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

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