MAX - SHOCK Clinical Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients age > 18 years.
Persistent atrial fibrillation.
Scheduled for elective cardioversion at UOHI
Patient is within the circle of care of UOHI Electrophysiology staff
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
biphasic defibrillator with maximum energy of 200J (® Zoll)
DeviceCardioversion
biphasic defibrillator with maximum energy of 360J (® Physio-Control)
DeviceCardioversion
Treatment groups
376 Participants
are divided into 2 treatment groupsGroup A: 200JActive comparator 1 intervention
Group B: 360JActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
ECV success
ECV success defined as \>\_2 consecutive sinus beats, or captured atrial-paced beats in patients with implanted cardiac devices, after shock delivery
Time frame
2 secondsSecondary outcomes
1
First shock success
Cardioversion is successful without crossover
Time frame
2 seconds2
sustained success
sustained sinus or atrial paced rhythm documented on 12-lead electrocardiogram
Time frame
4 hoursSponsors and contacts
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Source ClinicalTrials.gov