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NCT Number: NCT06556667

MAX - SHOCK Clinical 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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location status: Recruiting

Location contact

Dr. Mehrdad Golian

CONTACT

[email protected]

Dr. Mehrdad Golian

PRINCIPAL_INVESTIGATOR

Tammy Knight

CONTACT

[email protected]

About this study

Published estimates of ECV success using modern biphasic defibrillators vary considerably but most are limited by small sample sizes. Our pre-intervention ECV success rate of 91.8% was stable over >2.5 years and is comparable to a previous study from our institute11 and to recent estimates from moderately sized studies using contemporary technology. For instance, the Euro Heart Survey on AF reported an ECV success rate of 91% in 424 patients2 and the Biphasic Energy Selection for Transthoracic cardioversion of Atrial Fibrillation (BEST AF) trial reported 89% success in 380 patients.3 The variability in starting shock energy and shock energy escalation observed at our centre prior to implementing the OAFCP is also consistent with reported practices elsewhere. A recent survey of 57 European centres found that nearly two-thirds of hospitals started with a 100 J biphasic shock for AF whereas the remaining third started with 200 J.1 Considerable differences in electrode placement were also reported in this survey with 58.7% of centres using an anterolateral position and the remainder using an anteroposterior approach.1Our investigators and others have previously shown that physicians seldom apply sufficient force even when prompted to do so and even when using handheld paddles.10,16,17 ECV practices at our institute prior to implementing the OAFCP were therefore likely representative of those at most centres.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Known left-atrial appendage thrombus.
  • Contraindication to appropriate anticoagulation.
  • Patient is included in another randomized clinical trial.
  • Patient does not meet all of the above listed inclusion criteria.

Treatment and study plan

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

Device

Cardioversion

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

Device

Cardioversion

Primary outcomes

  1. ECV success

    Time frame: 2 seconds

    ECV success defined as >_2 consecutive sinus beats, or captured atrial-paced beats in patients with implanted cardiac devices, after shock delivery

Secondary outcomes

  1. First shock success

    Time frame: 2 seconds

    Cardioversion is successful without crossover

  2. sustained success

    Time frame: 4 hours

    sustained sinus or atrial paced rhythm documented on 12-lead electrocardiogram

Study contacts

Contact information is provided by the study sponsor or research team.

David Birnie

CONTACT

[email protected]

613-696-7000

Tammy Knight

CONTACT

[email protected]

613-696-7000 ext. 19080

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Acronym: MAX-SHOCK

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 16, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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