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Tiny trial tests ablation vs. pills for heart shock prevention

NCT ID NCT02114528

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two approaches to reduce shocks in people with an implantable defibrillator (ICD) who had dangerous heart rhythms. One group received antiarrhythmic drugs, the other had a catheter ablation procedure. The trial was a small pilot with only 3 participants and was terminated early, so no firm 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
Antiarrhythmic drugs (sotalol, mexiletine, procainamide, amiodarone) or catheter ablation
What this could lead to
If successful, this could show that catheter ablation is a better first-line option than drugs for preventing painful shocks from an ICD.
What could go wrong
This was a very small pilot trial (only 3 participants) that was terminated early, so results are not reliable. Both treatments have risks, including procedure complications or drug side effects.

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

3 people

The number who actually took part.

Start date

Oct 2014

Finished

Nov 2015

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 85 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: * ≥ 18 and ≤ 85 years old * Able to provide informed consent * AICD implanted for primary prophylaxis against sudden cardiac death * AICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes * CAD with prior myocardial infarction (\>60 days prior to enrollment) * AICD or ECG documentation of ventricular arrhythmia responsible for appropriate AICD therapy (\> 3 ATP or ≥ 1 appropriate Shock) Exclusion Criteria: * Contraindication or allergy to contrast media, routine procedural medications or catheter materials * Contraindication to an interventional procedure * Current or previous (within 3 months) antiarrhythmic therapy * Absolute contraindication to amiodarone or other AAD * New York Heart Association (NYHA) functional class IV * Stroke within the past 90 days * Unstable angina * Hypertrophic cardiomyopathy, Non-ischemic dilated cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Catecholamine sensitive polymorphic VT or long QT syndrome * Subjects with active ischemia that are eligible for revascularization * Life expectancy less than 6 months * Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation * Untreated hypothyroidism or hyperthyroidism. Subjects who are euthyroid on thyroid hormone replacement therapy are acceptable. * Current enrollment in another investigational drug or device study. * Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the Subject for the entire study period. * Absolute contra-indication to the use of heparin and or warfarin. * Documented intra-atrial thrombus, ventricular thrombus (\< 6 months after detection of thrombus), tumor, or another abnormality, which precludes catheter introduction. * Previous VT ablation * Are pregnant.

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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 Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

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