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One-Doctor sedation could speed up heart treatment

NCT ID NCT07571447

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Gødstrup Hospital

    Herning, Central Jutland, 7400, Denmark

  • Randers Regional Hospital

    Randers, Central Jutland, Denmark

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