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Heart shock therapy put to the test: Placebo-Controlled trial reveals true impact on daily life

NCT ID NCT05136131

Symptom relief Sponsor: Ottawa Heart Institute Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This study compares electrical cardioversion—a procedure that delivers a shock to restore normal heart rhythm—to a sham version where no shock is given. Researchers want to see if the real procedure truly improves quality of life in people with persistent atrial fibrillation, a common heart rhythm disorder. One hundred participants will be randomly assigned to receive either the real shock or the sham, and their quality of life will be measured using a standard survey.

What this could mean

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

Active substance
electrical cardioversion
What this could lead to
If it works, this could confirm that restoring normal heart rhythm with cardioversion meaningfully improves quality of life for people with persistent atrial fibrillation.
What could go wrong
This is a small, early-stage trial with only 100 participants. The sham control may reveal that the perceived benefit is partly due to a placebo effect, and results may not apply to all AF patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

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

Started

Feb 2023

Expected to finish

May 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: * Patients age ≥ 18 years * Persistent atrial fibrillation * Unknown symptom burden related to AF Exclusion Criteria: * Known left-atrial appendage thrombus * Prior catheter or surgical ablation for AF * Intolerance or contraindication to Amiodarone * Contraindication to appropriate anticoagulation * Patient is included in another randomized clinical trial * Patient is unable or unwilling to provide informed consent * Patient with a history of noncompliance with medical therapy * Patient does not meet all of the above listed inclusion criteria * Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrolment) * Breastfeeding * Patients for whom the investigator believes that the trial is not in the interest of the patient

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

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

  • Southlake Health

    RECRUITING

    Newmarket, Ontario, L3Y 2P9, Canada

  • University of Ottawa Heart Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

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