Cardiologist-Administered Midazolam vs. Anaesthesiologist-Assisted Propofol Sedation For Transoesophageal Echocardiography-Guided Cardioversion of Atrial Fibrillation

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorGødstrup Hospital

About this trial

Irregular heart rhythms, known as atrial fibrillation or atrial flutter, are common conditions that can increase the risk of stroke and heart failure. A standard treatment to restore a normal rhythm is a controlled electric shock, known as cardioversion. However, if the irregular rhythm has lasted more than 24 hours, if the duration is uncertain, and if the patient has not been on blood-thinning medication for at least three weeks, doctors must first check for blood clots in the heart. This is done using a special ultrasound scan of the heart through the food pipe.

Both the scan and the electric shock treatment require sedation to make the patient relaxed or asleep. The scan uses mild sedation from a cardiologist, while the shock needs a stronger sedative given by an anaesthesiologist. But needing this extra doctor can cause delays, so patients often wait longer for treatment and to go home.

This study will test whether a cardiologist can safely handle both steps using a sedative called midazolam. This study will include 220 adults at multiple hospitals in Denmark and compare this new approach to standard care. Researchers will track how quickly patients go home, how well the treatment works, any serious side effects, what patients think about the experience, and how much money can be saved.

If proven safe and effective, this new method could reduce treatment delays, shorten hospital stays, and lower healthcare costs-ultimately improving care for patients and making the healthcare system more efficient.

Eligibility criteria

Qualifiers

Adult patients (≥18 years) with atrial fibrillation or flutter

Scheduled for transoesophageal echocardiography-guided direct current cardioversion

Disqualifiers

Previous enrolment in the trial

Ongoing medical needs after cardioversion (e.g., decompensation or infection)

Planned procedures after cardioversion (same-day TTE or pacemaker test allowed)

Social barriers for same-day discharge

Trial design

Treatments tested in this trial

  • One-step cardiologist-only midazolam sedation
  • Two-step anaesthesiologist-assisted propofol sedation

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Gødstrup Hospital

Lead sponsor

University of Aarhus

Collaborator