What is the mechanism of action of this treatment?

Common treatments for Atrial Fibrillation (AF) include rhythm control and rate control strategies. Rhythm control aims to restore and maintain a normal heart rhythm using antiarrhythmic drugs or catheter-based ablation, which disrupts abnormal electrical signals in the heart. Rate control focuses on controlling the heart rate with medications like beta blockers, calcium channel blockers, or digoxin. These treatments are important for AF patients as they help manage symptoms and reduce the risk of complications such as stroke.

What side effects are associated with this type of intervention?

Catheter-based AF ablation, which disrupts abnormal electrical signals in the heart, can lead to complications such as bleeding, infection, cardiac tamponade, and pulmonary vein stenosis. Antiarrhythmic drugs like amiodarone and sotalol, used to maintain sinus rhythm, can cause side effects including thyroid dysfunction, liver toxicity, lung toxicity, and proarrhythmic effects. Both treatments require careful monitoring and follow-up to manage these potential risks.

What other types of research exist?

Promising novel alternatives to catheter-based AF ablation for 2024 include: 1) Antiarrhythmic drugs such as dronedarone, which has shown efficacy in maintaining sinus rhythm in patients with paroxysmal or persistent AF, though it is not recommended for permanent AF due to increased cardiovascular risks. 2) The ABC (Atrial Fibrillation Better Care) Pathway, which integrates anticoagulation, better symptom management, and cardiovascular risk factor optimization, has shown improved outcomes. 3) Mobile health technology for continuous monitoring and management of AF, which can enhance patient adherence and early detection of arrhythmia episodes. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Antiarrhythmic

Radiofrequency Ablation vs Antiarrhythmic Drugs for Atrial Fibrillation (RAAFT-3 Trial)

Q: What prior FDA approvals exist?

The FDA has approved several antiarrhythmic drugs for the treatment of Atrial Fibrillation, including amiodarone, sotalol, dofetilide, and dronedarone. These drugs aim to maintain sinus rhythm and manage symptoms. Additionally, catheter-based AF ablation, which disrupts abnormal electrical signals in the heart, is a significant treatment option. This procedure is often considered when medication is ineffective or not tolerated. The RAAFT-3 trial is studying the efficacy of catheter-based ablation as a first-line therapy compared to antiarrhythmic drugs for persistent AF.

Phase 3

Waitlist Available

Led By Andrea Natale, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Patients symptomatic with persistent AF

Be older than 18 years old

Must not have

Absolute contra-indication to the use of heparin and/or oral anticoagulation

Women with a positive pregnancy test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is investigating whether a procedure called catheter ablation is better than medication for treating patients with persistent atrial fibrillation who haven't yet tried specific heart medications. Catheter ablation involves using a thin tube to create small scars in the heart, which helps stop irregular heartbeats. The goal is to see if this procedure can more effectively control symptoms and improve quality of life compared to starting with medication. Catheter ablation has been shown to be more effective than medication at restoring normal heart rhythm and improving quality of life in patients with atrial fibrillation.

Who is the study for?

This trial is for adults over 18 with persistent atrial fibrillation (AF), which means their heart has been in an irregular rhythm for more than 7 days. They must have had at least two AF episodes in the past 9 months, documented by ECG. People can't join if they have severe heart issues, previous AF treatments, are pregnant, or have conditions that could interfere with the study.

What is being tested?

The RAAFT-3 trial is testing whether using a procedure called Radio Frequency Catheter Ablation to isolate pulmonary veins works better as a first treatment for persistent AF compared to standard antiarrhythmic drugs.

What are the potential side effects?

Possible side effects from ablation include bleeding or bruising at the catheter site, damage to blood vessels or heart tissue, and risks associated with anesthesia. Antiarrhythmic drugs may cause nausea, dizziness, fatigue or more serious effects like organ dysfunction.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have ongoing symptoms from atrial fibrillation.

Exclusion Criteria

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

Select...

I cannot use heparin or blood thinners.

Select...

I am currently pregnant.

Select...

I have had a procedure to treat irregular heartbeat.

Select...

I currently have a heart infection or a systemic infection.

Select...

I have taken medication for irregular heartbeat before.

Select...

I have severe heart artery blockage or had a recent heart bypass surgery.

Select...

I do not have severe lung problems like COPD.

Select...

I have a serious heart valve problem.

Select...

I cannot have a catheter ablation due to a clot or abnormality in my heart's left atrium.

Select...

I have a high risk of bleeding or a history of severe bleeding problems.

Select...

I cannot take any antiarrhythmic drugs like sotalol or amiodarone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 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

Recurrence of symptomatic Atrial Fibrillation

Secondary study objectives

AF/AT Burden

CV Hospitalizations

Quality of Life Questionnaire

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Antiarrhythmic MedicationsActive Control1 Intervention

Patients randomized to the antiarrhythmic drug group are administered medications approved for treatment of AF by the regulatory bodies of each participating country. The selection of antiarrhythmic drugs and dosages is left to the discretion of the investigator, and will follow the AHA/ACC/HRS general guidelines

Group II: Radio Frequency Catheter AblationActive Control1 Intervention

Patients randomized to radiofrequency catheter ablation will undergo isolation of the pulmonary veins with confirmation of entrance block into each vein. The CARTO TM(Biosense Webster, CA) system will be used to reconstruct the atrial geometry and assist for mapping and ablation. Ablation will be performed using approved ablation devices (Biosense Webster, CA).

0 / 12Eligibility 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

Common treatments for Atrial Fibrillation (AF) include rhythm control and rate control strategies. Rhythm control aims to restore and maintain a normal heart rhythm using antiarrhythmic drugs or catheter-based ablation, which disrupts abnormal electrical signals in the heart. Rate control focuses on controlling the heart rate with medications like beta blockers, calcium channel blockers, or digoxin. These treatments are important for AF patients as they help manage symptoms and reduce the risk of complications such as stroke.