MAX - SHOCK Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-09-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cardioversion Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

two arms will be compared using the Chi squared test

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

participants will not know which defibrillator was used during their cardioversion.

Study Groups

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200J

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Cardioversion

360J

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Cardioversion

Interventions

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

Cardioversion

Intervention Type DEVICE

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

Cardioversion

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No