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

NCT07571447 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Fibrillation (AF)
  • Atrial Flutter

Interventions

OTHER

One-step cardiologist-only midazolam sedation

TOE-guided DCC performed under continuous cardiologist-administered midazolam sedation, without anaesthesiologist involvement. Midazolam is administered intravenously at the discretion of the treating cardiologist. Non-binding dosing guidance is provided to support clinical practice, but dosing may be individualised as clinically indicated. * For the TOE phase, suggested dosing includes an initial IV dose of 1.25-5.0 mg, with repeat doses of 1.25-2.5 mg as needed, and a suggested maximum cumulative dose of 20 mg. * For the DCC phase, suggested dosing includes an initial IV dose of 2.5-7.5 mg, with repeat doses of 2.5 mg as needed. A suggested maximum cumulative dose of 25 mg applies, including doses administered during the TOE phase.

OTHER

Two-step anaesthesiologist-assisted propofol sedation

TOE performed under cardiologist-administered sedation followed by a wake-up period and subsequent DCC performed under propofol sedation administered by an anaesthesiologist. Sedation for TOE and DCC is administered following established local guidelines.

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • Gødstrup Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07571447 on ClinicalTrials.gov