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Clinical Trials/NCT06556667
NCT06556667RecruitingNot Applicable

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

Ottawa Heart Institute Research Corporation1 site in 1 country376 target enrollmentStarted: March 31, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
376
Locations
1
Primary Endpoint
ECV success

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

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

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

200J

Active Comparator

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

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

360J

Active Comparator

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

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

Outcomes

Primary Outcomes

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

  • First shock success(2 seconds)
  • sustained success(4 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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