Defibrillator Energy Levels for Atrial Fibrillation

(MAX-SHOCK Trial)

Overseen By David Birnie

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Left-atrial thrombus, Anticoagulation contraindication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Single session

379 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Electrical Cardioversion (ECV) to determine if it can more effectively restore normal heart rhythm in people with atrial fibrillation (AF), a condition characterized by an irregular heartbeat. The goal is to assess whether a higher energy level of 360 joules is more effective than a lower energy level of 200 joules. Individuals with persistent AF who are scheduled for an elective cardioversion procedure may be suitable candidates, particularly if they are already consulting specialists at the University of Ottawa Heart Institute (UOHI). As an unphased trial, this study provides patients the chance to contribute to significant research that could enhance treatment options for AF.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for atrial fibrillation?

Previous studies found that using a 200J energy level for electrical cardioversion safely and effectively restores the heart's normal rhythm. Research shows that shocks from a biphasic defibrillator at or below 200J are generally well-tolerated, with no major safety issues and effective results.

Studies found the 360J energy level even more successful than 200J in restoring normal heart rhythm, suggesting greater effectiveness. Safety data for 360J shows no significant increase in side effects compared to lower energy levels.

Overall, both 200J and 360J treatments have been tested and are considered safe, with no major safety concerns reported in studies. This suggests that both energy levels are well-tolerated by patients undergoing electrical cardioversion for atrial fibrillation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Defibrillator Energy Levels for Atrial Fibrillation trial because it investigates how different energy levels affect electrical cardioversion, a common treatment for atrial fibrillation. Traditional cardioversion often uses a standard energy dose, but this study compares two specific energy levels: 200 joules and 360 joules, using advanced biphasic defibrillators. The potential to optimize the energy level could lead to more efficient and effective treatments, reducing the need for repeated shocks and improving patient outcomes. By understanding which energy level works best, this trial aims to enhance the safety and success rate of cardioversion for atrial fibrillation patients.

What evidence suggests that this trial's treatments could be effective for atrial fibrillation?

This trial will compare the effectiveness of two different energy levels for electrical cardioversion in treating atrial fibrillation. Research has shown that a 360J electrical shock is more successful in restoring normal heart rhythm in patients with atrial fibrillation (AF). One study found that 96% of patients treated with 360J returned to a normal rhythm, compared to 75.4% with 200J. Another study reported a 56% success rate for a 360J shock in AF lasting more than 30 days, significantly higher than with lower energy levels. These findings suggest that higher energy levels might be more effective for treating AF. However, both energy levels are generally considered safe and effective for many patients. Participants in this trial will receive either the 200J or 360J energy level to evaluate their effectiveness and safety. ^{2 5 6 7 8}

Who Is on the Research Team?

Mehrdad Golian

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

The MAX-SHOCK trial is for patients with persistent atrial fibrillation who are scheduled for elective cardioversion at UOHI and under the care of UOHI Electrophysiology staff. It's not specified who can't join.

Inclusion Criteria

I am a patient under the care of UOHI Electrophysiology staff.

I have ongoing atrial fibrillation.

I am scheduled for a procedure to correct my heart rhythm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Electrical Cardioversion (ECV) using either a 200J or 360J biphasic defibrillator to restore sinus rhythm

Single session

1 visit (in-person)

Follow-up

Participants are monitored for sustained success of cardioversion and rhythm stability

4 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Electrical Cardioversion

Trial Overview This study tests whether a higher energy biphasic defibrillator (360J by Physio-Control) is more effective in restoring normal heart rhythm during Electrical Cardioversion (ECV) compared to a lower energy one (200J by Zoll).

How Is the Trial Designed?

Group I: 200J Active Control 1 Intervention

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

Group II: 360J Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1767835/

Comparison of monophasic and biphasic shocks for ... Results: 70% of 109 patients treated with an initial 200 J monophasic shock were cardioverted to sinus rhythm, compared with 80% of 118 patients treated with ...

2. ahajournals.org ahajournals.org/doi/10.1161/circ.102.suppl_1.I-90

Part 6: Advanced Cardiovascular Life Support | Circulation Current research confirms that biphasic shock energies ≤200 J are safe and effective. Even though both escalating- and nonescalating-energy defibrillators are ...

3. academic.oup.com academic.oup.com/europace/article/25/2/318/6887862

Techniques improving electrical cardioversion success for ... High-energy shocks using at least 200 J increased initial success by approximately 60%. Biphasic, high-energy shocks can increase efficacy and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0735109701015406

Initial energy setting, outcome and efficiency in direct ... In AF of >30 days duration, shocks of <200 J had a 6.1% probability of success; this fell to 2.2% with a duration >180 days. In those with AF for >180 days, the ...

5. cda-amc.ca cda-amc.ca/sites/default/files/pdf/K0152_200J_and_360J_Biphasic_Defibrillators_final.pdf

200J Rectilinear Biphasic Waveform and 360J Truncated ... The identified observational study examined the effectiveness of an escalating protocol to deliver shocks with a truncated biphasic waveform defibrillator with ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/14516881/

Comparison of the efficacy and safety of two biphasic ... One hundred patients were successfully converted to sinus rhythm (99% success rate). There was no difference in efficacy at any energy level used, regardless of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04032678

Comparison of Efficacy and Safety of Two Biphasic ... The secondary CVS safety outcome measures: Biochemical markers for myocardial necrosis (high sensitive troponin I - hsTnI, creatine kinase MB fraction - CK-MB) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6192814/

Electric Cardioversion of Atrial Fibrillation - PMC EC is safe, effective and reliable method for aborting AF especially in unstable situations. Numerous technical and patient characteristics contribute to the ...