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Double shock heart treatment trial fizzles out

NCT ID NCT03943693

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tested whether giving two quick electrical shocks instead of one could better restore a normal heart rhythm in people with atrial fibrillation. It focused on patients with factors that make standard shock treatment less likely to work, such as obesity or lung disease. However, the study was stopped early after enrolling only 5 people, so no meaningful conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
electrical shock (cardioversion)
What this could lead to
If it worked, this could point toward a better way to restore normal heart rhythm in people with atrial fibrillation who are harder to treat.
What could go wrong
This was a very early, tiny trial that was stopped before completion. The results are not reliable, and the approach may not be safer or more effective than standard care.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

5 people

The number who actually took part.

Started

Apr 2019

Finished

May 2021

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 to 80 years

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: * Outpatient or inpatients with atrial fibrillation sent for elective direct current cardioversion (DCCV) with at least 1 of the following risk factors will be included: * BMI \>30 * History of Chronic Obstructive Pulmonary Disease/emphysema/asthma * Significant Valvular heart disease (at least moderate regurgitation/stenosis) * History of Heart Failure with preserved Ejection Fraction/Heart Failure with reduced Ejection Fraction * Cardiomyopathy with ejection fraction \<40% * Left atrium anterior-posterio (AP) dimension \>4.5cm * Presence of Left ventricular hypertrophy (≥1.1cm septal/posterior wall M-mode) on transthoracic echocardiogram * History of sleep apnea Exclusion Criteria: * Consent not obtained * \<18 y.o. * \>80 y.o. * Not adequately anti-coagulated * Patient hemodynamically unstable and DCCV required as an emergent procedure * Prisoners or pregnant patients

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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.

Contacts and locations

Locations

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73105, United States

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