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View on ClinicalTrials.gov

Testing biphasic defibrillator with maximum for cardioversion

Official title: MAX - SHOCK Clinical Trial

Comparison of Maximum Energy Shocks From Two Defibrillator Vendors MAX - SHOCK- A Randomized Controlled Clinical Trial

Condition: CardioversionSponsor: Ottawa Heart Institute Research CorporationTarget enrollment: 376
  • 2 groups
  • One site, in Ottawa
  • Recruiting
University of Ottawa Heart Institute, Ottawa, Ontario

Interventions

  • Medical device

    biphasic defibrillator with maximum energy of 200J (® Zoll)

    Cardioversion

  • Medical device

    biphasic defibrillator with maximum energy of 360J (® Physio-Control)

    Cardioversion

Canadian Sites (1)

1 of 1 recruiting

  • University of Ottawa Heart Institute

    Ottawa, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for8 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Patients age \> 18 years.
  • +Persistent atrial fibrillation.
  • +Scheduled for elective cardioversion at UOHI
  • +Patient is within the circle of care of UOHI Electrophysiology staff

Exclusion

  • Known left-atrial appendage thrombus.
  • Contraindication to appropriate anticoagulation.
  • Patient is included in another randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → clinical trialInterventional studyA study where participants are given something to see what happens.Read more →.
  • Patient does not meet all of the above listed inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A, the comparison group, receives biphasic defibrillator with maximum energy of 200J (® Zoll).

Registry label: A: 200J

Group B, the comparison group, receives biphasic defibrillator with maximum energy of 360J (® Physio-ControlControl groupThe group a new treatment is measured against.Read more →).

Registry label: B: 360J

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 376 people.

The study is currently expected to finish around September 2027.

The main measurement is taken over: 2 seconds.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

ECV success — measured over 2 seconds.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06556667 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About biphasic defibrillator with maximum energy of 200J (® Zoll)Device

Cardioversion

From the trial registry — its own words, unedited.

What a device is here: A physical instrument, implant, app or piece of equipment being studied.

Read the full explanation → · in clinical review

About biphasic defibrillator with maximum energy of 360J (® Physio-Control)Device

Cardioversion

From the trial registry — its own words, unedited.

What a device is here: A physical instrument, implant, app or piece of equipment being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: 2 seconds.

The study as a whole is currently expected to finish around 2027-09-01.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 376 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Ottawa, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

Can Electrical Cardioversion (ECV) for AF be improved. It is the preferred method to restore sinus rhythm in patients with AF in whom a rhythm-control strategy is pursued. Hypothesis: ECV success rates will be greater with a biphasic defibrillator with maximum energy of 360J (® Physio-Control) compared to a biphasic defibrillator with maximum energy of 200J (® Zoll)

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.