Cardioversion for Atrial Fibrillation

(QOL-CAFRCT Trial)

Overseen By Mouhannad Sadek, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Must not be taking: Amiodarone

Disqualifiers: Thrombus, Prior ablation, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how electrical cardioversion, a procedure that resets the heart's rhythm, affects the quality of life for individuals with persistent atrial fibrillation. It compares real cardioversion to a sham (fake) procedure to determine if restoring normal heart rhythm genuinely improves symptoms such as fatigue and shortness of breath. Individuals with persistent atrial fibrillation who are uncertain about the connection between their symptoms and their condition might be well-suited for this study. As an unphased trial, this study provides a unique opportunity to explore how cardioversion impacts daily life and symptoms.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

What prior data suggests that cardioversion is safe for atrial fibrillation?

Research has shown that electrical cardioversion is generally safe for most people with atrial fibrillation. Studies have found that this procedure successfully restores normal heart rhythm in about 90% of cases. In one study, unexpected reactions occurred in only 3.6% of patients shortly after the procedure, while 8.2% experienced issues later. Another study involving 400 patients reported no major problems, such as stroke, after the procedure. This evidence suggests that electrical cardioversion is well-tolerated and carries a low risk of serious side effects for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares the effectiveness of true electrical cardioversion to a sham procedure for treating atrial fibrillation. Most standard treatments for this condition involve medication or true electrical cardioversion, where a controlled electric shock helps reset the heart's rhythm. The trial could reveal whether the physical act of cardioversion or the psychological effect of receiving the treatment plays a more significant role in patient outcomes. This could lead to a better understanding of how to optimize treatments and enhance patient care by potentially reducing unnecessary procedures.

What evidence suggests that cardioversion is effective for improving quality of life in atrial fibrillation?

Research has shown that electrical cardioversion effectively treats atrial fibrillation (AF), with about a 90% success rate in restoring a normal heart rhythm. This trial will compare true electrical cardioversion with a sham procedure. Patients generally tolerate the true cardioversion procedure well, and it can quickly restore the heart's regular beat, potentially improving symptoms like shortness of breath and tiredness. However, while cardioversion can relieve symptoms, it does not necessarily reduce the long-term risks of heart failure or stroke. The decision to use cardioversion often depends on the impact of AF symptoms on a person’s daily life. ^{2 6 7 8 9}

Who Is on the Research Team?

David Birnie, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for adults over 18 with persistent atrial fibrillation (AF), an irregular heart rhythm, who haven't had their symptoms assessed yet. It's not for pregnant or breastfeeding individuals, those in another clinical trial, unable to consent, with a history of noncompliance to medical therapy, intolerance to Amiodarone, contraindications to anticoagulation, known left-atrial appendage thrombus or prior ablations for AF.

Inclusion Criteria

I am unsure about the symptoms caused by my atrial fibrillation.

I have ongoing irregular heartbeats.

Exclusion Criteria

Patients for whom the investigator believes that the trial is not in the interest of the patient

I cannot take blood thinners due to health reasons.

Patient does not meet all of the above listed inclusion criteria

Timeline for a Trial Participant

Pre-cardioversion

Participants undergo a 4-week phase of medical optimization including anticoagulation assessment/initiation, initiation of Amiodarone, and rate-control medications.

4 weeks

1 visit (in-person) for baseline echocardiogram

Cardioversion Procedure

Participants undergo either true cardioversion or sham cardioversion following anesthesia administration.

1 day

1 visit (in-person)

Post-cardioversion Monitoring

Participants wear a patch Holter monitor for 4 weeks and complete quality of life questionnaires.

4 weeks

1 visit (in-person) for ECG and questionnaires

Follow-up

Participants have a follow-up with their MRP cardiologist to discuss further treatment.

2 weeks

1 visit (telephone or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Electrical cardioversion
• Sham electrical cardioversion

Trial Overview The study tests if electrical cardioversion—a procedure that restores normal heart rhythm—improves quality of life compared to a fake (sham) procedure. Participants are randomly assigned to receive either the real treatment or sham and will be monitored for changes in their well-being.

How Is the Trial Designed?

Group I: True cardioversion Experimental Treatment 1 Intervention

Following anaesthesia administration, the unblinded team (non-MRP cardiologist / anesthesiologist will open the envelope indicating which arm the patient has been randomized to. Other members of the team will step out of the room. The unblinded non-MRP cardiologist will call out as per usual "All clear", following which a shock is delivered as per the Ottawa Cardioversion Protocol in the 'shock' arm.

Group II: Sham cardioversion Placebo Group 1 Intervention

Following anaesthesia administration, the unblinded team (non-MRP cardiologist / anesthesiologist will open the envelope indicating which arm the patient has been randomized to. Other members of the team will step out of the room. No shock is delivered in the "sham" shock arm.

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/PMC4414802/

Outcomes Following Non-Emergent Electrical ... Among the 75% of patients who ultimately underwent cardioversion in RHYTHM-AF, conversion to normal sinus rhythm was successful in 90%, with very low rates of ...

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

Techniques improving electrical cardioversion success for ... Electrical cardioversion is commonly used to restore sinus rhythm in patients with atrial fibrillation (AF), but procedural technique and clinical success vary.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0033062025000878

Strategies for optimizing efficacy of electrical cardioversion ... Electrical cardioversion is effective and well tolerated, and can rapidly and safely return patients with atrial fibrillation to sinus rhythm.

4. cureus.com cureus.com/articles/362017-effectiveness-of-immediate-pharmacological-versus-electrical-cardioversion-on-hemodynamic-stability-and-rhythm-restoration-in-patients-with-refractory-atrial-fibrillation-a-systematic-review

Effectiveness of Immediate Pharmacological Versus ... ECV and PCV are both effective strategies for rhythm restoration in acute AF management within emergency settings, with comparable overall success rates.

5. bmccardiovascdisord.biomedcentral.com bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-024-03885-0

Atrial fibrillation: real-life experience of a rhythm control with ... The overall effectiveness of the procedure was 92%. Effectiveness was similar across all prespecified subgroups. Electrical cardioversion was ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/j.1553-2712.2010.00697.x

Thirty‐day Outcomes of Emergency Department Patients ... In this study of 400 ED patients who underwent DCCV for atrial fibrillation or flutter, none suffered significant complications, stroke, new ...

7. jacc.org jacc.org/doi/10.1016/j.jacep.2017.04.004

Outcomes Associated With Electrical Cardioversion for ... The main finding of this study is that elective CVs for AF can be performed safely and with a 95% success rate autonomously by an APP who has ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6453693/

Effectiveness and safety of electrical cardioversion for ... Electrical cardioversion is an effective and safe procedure in the vast majority of patients, albeit less effective in patients aged >80 years.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016752730500197X

Outpatient electrical cardioversion of atrial fibrillation AF could be terminated with a mean of 1.4 shocks in all patients. Acute adverse events could be observed in 3.6%. Late adverse events were noted in 8.2%.