Double shock heart treatment trial fizzles out
NCT ID NCT03943693
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 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: * 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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