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New drug may offer safer, faster fix for Post-Surgery heart flutter

NCT ID NCT04748991

Disease control Sponsor: University of Calgary Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a newer drug, Vernakalant, works better than the standard Amiodarone for treating atrial fibrillation (irregular heartbeat) that often occurs after heart surgery. About 50 adults who recently had heart surgery will receive one of the two drugs. The main goal is to see which drug restores normal heart rhythm faster and with fewer side effects, like drops in blood pressure.

What this could mean

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

Active substance
Vernakalant (also known as BRINAVESS) and Amiodarone (also known as Cordarone, Nexterone, Pacerone)
What this could lead to
If Vernakalant works better, it could offer a faster, safer way to restore normal heart rhythm after heart surgery, reducing time in the ICU and need for blood pressure medications.
What could go wrong
This is a small early-phase trial with only 50 participants, so results may not apply to everyone. Vernakalant may not be more effective than the standard drug Amiodarone, and side effects are still possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 50 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 2029

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: 1. Age \>/=18 years 2. Undergone heart surgery for coronary artery bypass surgery (on-pump or off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations. 3. Hemodynamically stable with/without vasopressor support Exclusion Criteria: 1. LVAD insertion or heart transplantation 2. MAZE procedure 3. Transcatheter aortic valve replacement (TAVR) 4. History of or planned mechanical valve replacement 5. Rheumatic heart disease 6. Congenital cardiac defect (excluding bicuspid aortic valve or patent foramen ovale) 7. History of prior atrial fibrillation or flutter 8. History of ablation for atrial fibrillation 9. Contraindication to amiodarone * PR \>240ms * Heart block (2nd or 3rd degree) * QTC \>480ms * Untreated thyroid disorder * AST or ALT \>2x upper limit of normal * Hepatic cirrhosis * Interstitial lung disease 10. Received amiodarone within 6 weeks 11. Contraindications to Vernakalant * Known hypersensitivity to Vernakalant * Prolonged QT * Heart block (2nd or 3rd degree) * Use of anti-arrhythmic medication in the past 4 weeks. 12. Return to OR during CVICU stay or readmission to CIVCU from Cardiac Surgery ward.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation Post-cardiac surgery

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.