NCT06556667

MAX - SHOCK Clinical Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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

• Cardioversion
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	biphasic defibrillator with maximum energy of 200J (® Zoll)	Cardioversion
DEVICE	biphasic defibrillator with maximum energy of 360J (® Physio-Control)	Cardioversion

Timeline

• Start date: 2025-03-31
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-08-16
• Last updated: 2026-02-03

Locations

1 site across 1 country: Canada