What side effects are associated with this type of intervention?

The most common treatments for atrial fibrillation (AF) include pharmacologic and electrical cardioversion. Pharmacologic cardioversion involves antiarrhythmic drugs such as flecainide, propafenone, amiodarone, and ibutilide. These drugs can cause side effects like transient hypotension, QTc interval prolongation, and proarrhythmia, including torsades de pointes. Flecainide and propafenone should not be used in patients with structural heart disease due to the risk of serious arrhythmias. Electrical cardioversion, while highly effective, requires sedation and carries risks associated with anesthesia, as well as potential for skin burns and arrhythmic complications. Both methods aim to restore sinus rhythm but must be carefully chosen based on individual patient profiles to minimize adverse effects.

What prior FDA approvals exist?

Several drugs have been FDA-approved for the treatment of Atrial Fibrillation, particularly for cardioversion to restore sinus rhythm. Flecainide and propafenone are effective for pharmacologic conversion of AF, especially in patients without structural heart disease. Amiodarone and ibutilide are also used, with amiodarone being preferred in cases with structural heart disease. Dofetilide is another option, primarily used to maintain sinus rhythm post-cardioversion. These drugs have been studied extensively for their efficacy and safety in converting AF to sinus rhythm.

What other types of research exist?

Promising novel alternatives to cardioversion for atrial fibrillation patients include: 1) Dronedarone and dofetilide, which have shown efficacy in maintaining sinus rhythm. 2) Catheter ablation, which is increasingly being used for long-term rhythm control. 3) Angiotensin II receptor blockers (ARBs) like irbesartan and valsartan, which have shown potential in maintaining sinus rhythm in some studies. These alternatives offer different mechanisms of action and may be suitable for patients with varying clinical profiles.

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Cardioversion for Atrial Fibrillation (QOL-CAFRCT Trial)

N/A

Recruiting

Led By David Birnie, MD

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients age ≥ 18 years

Persistent atrial fibrillation

Must not have

Contraindication to appropriate anticoagulation

Intolerance or contraindication to Amiodarone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Summary

This trial is testing whether using an electric shock to reset the heart's rhythm improves the quality of life for patients with persistent irregular heartbeats. The goal is to see if resetting the heart's rhythm makes patients feel better.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, generally cardioversion can cause skin irritation where paddles are placed; rare complications may include abnormal heart rhythms. The sham procedure should have no side effects as it mimics the actual process without delivering any treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have ongoing irregular heartbeats.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take blood thinners due to health reasons.

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I cannot take Amiodarone due to side effects or health reasons.

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I have had a procedure to treat atrial fibrillation.

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I cannot or do not want to give permission for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference between AFEQT Scores pre and post cardioversion

Secondary study objectives

Absolute AFEQT score post-cardioversion

Change in daily activity

Change in generic quality of life

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: True cardioversionExperimental Treatment1 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 cardioversionPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Electrical cardioversion

2014

N/A

~440

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cardioversion, either electrical or pharmacologic, aims to restore normal sinus rhythm in patients with Atrial Fibrillation (AF). Electrical cardioversion uses direct current shocks to reset the heart's electrical activity, while pharmacologic cardioversion employs antiarrhythmic drugs like amiodarone or flecainide to stabilize the heart's rhythm. These treatments are crucial for AF patients as they can alleviate symptoms such as shortness of breath, fatigue, and palpitations, thereby improving quality of life. Additionally, maintaining sinus rhythm can reduce the risk of stroke and heart failure associated with AF.