One-Doctor sedation could speed up heart treatment
NCT ID NCT07571447
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study compares two ways to sedate patients during a heart scan and electric shock treatment for atrial fibrillation. Currently, a cardiologist gives mild sedation for the scan, but an anaesthesiologist must give stronger sedation for the shock, causing delays. Researchers want to see if a cardiologist can safely handle both steps using midazolam alone. The trial will include 220 adults in Denmark and measure how quickly patients go home, treatment success, side effects, and costs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- midazolam
- What this could lead to
- If this works, it could mean faster treatment and shorter hospital stays for people with atrial fibrillation needing a heart scan and shock.
- What could go wrong
- This is a phase 4 trial with 220 people, so results may not apply to everyone. Midazolam may not provide enough sedation for some patients, requiring extra help.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patients (≥18 years) with atrial fibrillation or flutter * Scheduled for transoesophageal echocardiography-guided direct current cardioversion Exclusion Criteria: 1. Previous enrolment in the trial 2. 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 3. 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 4. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gødstrup Hospital
Herning, Central Jutland, 7400, Denmark
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Randers Regional Hospital
Randers, Central Jutland, Denmark
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