What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation include antiarrhythmic drugs and catheter ablation. Antiarrhythmic drugs such as dronedarone, sotalol, dofetilide, and amiodarone can have significant side effects. Dronedarone has been associated with an increased risk of cardiovascular events, including stroke and heart failure, particularly in patients with permanent AF. Sotalol and dofetilide can cause QT interval prolongation, leading to potentially life-threatening arrhythmias. Amiodarone, while effective, has numerous side effects including thyroid dysfunction, pulmonary toxicity, and liver damage. Catheter ablation, particularly pulmonary vein isolation, is generally effective but carries risks such as bleeding, infection, and damage to the heart or surrounding structures, and has a variable success rate, especially in persistent AF.

What prior FDA approvals exist?

The FDA has approved several antiarrhythmic drugs for the treatment of Atrial Fibrillation (AF), including dronedarone, flecainide, propafenone, and dofetilide. Dronedarone has been shown to reduce cardiovascular events in patients with paroxysmal or persistent AF but is not recommended for those with permanent AF due to increased risks. Flecainide and propafenone are effective for converting AF to sinus rhythm, particularly in patients without structural heart disease. Dofetilide is primarily used to maintain sinus rhythm in patients with persistent AF and can be used in those with structural heart disease. These treatments aim to manage the arrhythmia and prevent recurrence, similar to the goals of the Ultra-High Resolution CT trial assessing peri-atrial inflammatory fat tissue.

What other types of research exist?

Promising alternatives to Ultra-High Resolution CT for assessing peri-atrial inflammatory fat tissue in AF patients include: 1) Cardiovascular Magnetic Resonance (CMR) with T1 and T2 mapping, which can identify myocardial inflammation and fibrosis; 2) 18F-Sodium Fluoride PET/MR, which offers detailed imaging of cardiac inflammation and amyloidosis; and 3) Noncontrast T1 mapping, which is effective in diagnosing cardiac amyloidosis and may provide insights into inflammatory changes.

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Procedure

Catheter Ablation for Atrial Fibrillation

Q: What is the mechanism of action of this treatment?

Atrial Fibrillation (AF) treatments primarily aim to control heart rate, restore and maintain normal rhythm, and prevent thromboembolism. Rate control is achieved using medications like beta-blockers or calcium channel blockers to slow the heart rate. Rhythm control involves antiarrhythmic drugs or procedures like electrical cardioversion and catheter ablation to restore normal heart rhythm. Catheter ablation, particularly pulmonary vein isolation (PVI), targets the electrical pathways causing AF. Recent studies, such as those using Ultra-High Resolution CT, have identified peri-atrial inflammatory fat tissue as a factor in AF recurrence, suggesting that targeting this inflammation could improve ablation success rates. Understanding these mechanisms helps AF patients and their doctors choose the most effective treatment strategy, potentially reducing recurrence and improving quality of life.

N/A

Waitlist Available

Led By Hiroshi Ashikaga, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Ages 18 to 100 years

Be older than 18 years old

Must not have

Inability to provide consent

Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial investigates a procedure to treat irregular heartbeats in adults with atrial fibrillation. It includes targeting inflamed fat around the heart to see if it helps prevent recurrence. The study focuses on patients who have not fully responded to standard treatments.

Who is the study for?

This trial is for adults aged 18 to 100 who are undergoing their first catheter ablation for atrial fibrillation and need a cardiac CT scan. It's not suitable for those unable to consent, with severe kidney issues (eGFR <30), or with a known severe allergy to contrast dye used in scans.

What is being tested?

The study is testing the significance of peri-atrial inflammatory fat tissue in atrial fibrillation by using high-resolution CT scans. The goal is to see if this fat tissue can predict recurrence after the ablation procedure.

What are the potential side effects?

Potential side effects may include reactions related to the catheter ablation like bleeding or infection at the insertion site, heart damage, and risks associated with CT scans such as exposure to radiation and allergic reactions to contrast dye.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 100 years old.

Exclusion Criteria

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

Select...

I am unable to give consent by myself.

Select...

My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Freedom from any documented episode of AF

Secondary study objectives

Freedom from any documented atrial arrhythmia after one ablation procedure

Freedom from any documented atrial arrhythmia after two ablation procedures

Freedom from documented AF after two ablation procedures

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 3: Persistent AF - PVI + Fat-targeted ablationExperimental Treatment1 Intervention

The subjects with persistent AF undergo pulmonary vein isolation (PVI) and additional ablation to target the inflammatory fat tissue

Group II: Arm 2: Persistent AF - PVI armPlacebo Group1 Intervention

The subjects with persistent AF undergo pulmonary vein isolation (PVI).

Group III: Arm 1: Paroxysmal AF - PVI armPlacebo Group1 Intervention

The subjects with paroxysmal AF undergo pulmonary vein isolation (PVI).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Catheter ablation

2016

Completed Phase 4

~1260

0 / 3Eligibility 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

Atrial Fibrillation (AF) treatments primarily aim to control heart rate, restore and maintain normal rhythm, and prevent thromboembolism. Rate control is achieved using medications like beta-blockers or calcium channel blockers to slow the heart rate. Rhythm control involves antiarrhythmic drugs or procedures like electrical cardioversion and catheter ablation to restore normal heart rhythm. Catheter ablation, particularly pulmonary vein isolation (PVI), targets the electrical pathways causing AF. Recent studies, such as those using Ultra-High Resolution CT, have identified peri-atrial inflammatory fat tissue as a factor in AF recurrence, suggesting that targeting this inflammation could improve ablation success rates. Understanding these mechanisms helps AF patients and their doctors choose the most effective treatment strategy, potentially reducing recurrence and improving quality of life.