Mild Sedation Method for Heart Rhythm Procedure in Atrial Fibrillation Patients

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with paroxysmal or persistent atrial fibrillation who are having pulsed-field ablation and agree in writing to take part.

Age

Above 18 years

Sex

All sexes can join.

Disease stage

Paroxysmal or persistent atrial fibrillation (AF).

Earlier treatment

People taking benzodiazepine drugs (or other sedative drugs, at the anaesthesiologist's discretion) cannot join.

Main reasons for not taking part

• BMI above 35kg/m2
• Left ventricle ejection fraction (EF) below 40%
• Sleep apnoea (OSA) syndrome on therapy, or an expected difficult airway
• Severe COPD, severe pulmonary hypertension, or significant valve disease (3/4 or more)
• Symptomatic heart failure or myasthenia gravis

The registry criteria, word for word

What the trial wants to find out

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.

The group in the trial

• 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.