MAX - SHOCK Clinical Trial
MAX-SHOCK
Comparison of Maximum Energy Shocks From Two Defibrillator Vendors MAX - SHOCK- A Randomized Controlled Clinical Trial
1 other identifier
interventional
376
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2024
CompletedFirst Posted
Study publicly available on registry
August 16, 2024
CompletedStudy Start
First participant enrolled
March 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
February 3, 2026
January 1, 2026
2.4 years
July 31, 2024
January 30, 2026
Conditions
Keywords
Outcome Measures
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
2 seconds
Secondary Outcomes (2)
First shock success
2 seconds
sustained success
4 hours
Study Arms (2)
200J
ACTIVE COMPARATORbiphasic defibrillator with maximum energy of 200J (® Zoll)
360J
ACTIVE COMPARATORbiphasic defibrillator with maximum energy of 360J (® Physio-Control)
Interventions
Eligibility Criteria
You may qualify if:
- Patients age \> 18 years.
- Persistent atrial fibrillation.
- Scheduled for elective cardioversion at UOHI
- Patient is within the circle of care of UOHI Electrophysiology staff
You may not qualify if:
- Known left-atrial appendage thrombus.
- Contraindication to appropriate anticoagulation.
- Patient is included in another randomized clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehrdad Golian
Ottawa Heart Institute Research Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- participants will not know which defibrillator was used during their cardioversion.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2024
First Posted
August 16, 2024
Study Start
March 31, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
February 3, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share