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NCT07571447Not yet recruitingPhase 4

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

Cardiologist-Administered Midazolam vs. Anaesthesiologist-Assisted Propofol Sedation For Transoesophageal Echocardiography-Guided Cardioversion of Atrial Fibrillation (CARDIOZOLAM-1)

Source: ClinicalTrials.gov · Last updated 8 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
220 (estimated)
First submitted
24 Apr 2026
Start date
Sept 2026
Primary completion date
Sept 2027
Lead sponsor
Gødstrup Hospital
NCT number
NCT07571447

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 220
  • From Sept 2026 to the primary completion date, Sept 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous enrolment in the trial
  • Indication for anaesthesiology assistance:
    • Haemodynamic instability (systolic blood pressure \<90 mmHg)
    • Known severe pulmonary disease (FVC or FEV1 \<50% predicted)
    • Body mass index \>40 kg/m2
    • Previous complications or allergic reactions to sedation

Other illness

  • Expected prolonged hospitalisation (\>8 hours) despite sinus rhythm restoration:
    • 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

Other

  • Contraindications:
    • Pregnant or breastfeeding
    • Intracardiac thrombus
    • Total benzodiazepine dose used for TOE \>20 mg
    • Abbreviations: FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; TOE, transoesophageal echocardiography; TTE, transthoracic echocardiography.

Who the study is looking for

  • Adult patients (≥18 years) with atrial fibrillation or flutter
  • Scheduled for transoesophageal echocardiography-guided direct current cardioversion

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gødstrup Hospital
Coordinator of this site? Confirm its status
HerningDenmarkUnknown status
Randers Regional Hospital
Coordinator of this site? Confirm its status
RandersDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.