What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation, such as antiarrhythmic drugs and ablation procedures, have various side effects. Antiarrhythmic drugs like dronedarone can increase the risk of cardiovascular events, including stroke, myocardial infarction, and heart failure. Ablation procedures, including pulmonary vein isolation (PVI) and FIRM-guided ablation, can lead to complications such as bleeding, infection, and damage to the heart or nearby structures. These procedures may also require repeat interventions if initial attempts are not successful.

What prior FDA approvals exist?

The FDA has approved several antiarrhythmic drugs for the treatment of Atrial Fibrillation, including sotalol, dronedarone, dofetilide, and amiodarone. These drugs help maintain sinus rhythm in patients with AF. In terms of ablation techniques, pulmonary vein isolation (PVI) is a well-established method that targets the pulmonary veins to prevent AF. Recent studies have explored combining PVI with focal impulse and rotor modulation (FIRM) to target specific areas sustaining AF, although the clinical benefits of this combined approach are still under evaluation.

What other types of research exist?

Promising novel alternatives to FIRM-guided ablation (FIRM+PVI) for atrial fibrillation patients include: 1) Cryoballoon ablation, which isolates pulmonary veins using extreme cold, 2) Laser balloon ablation, which uses laser energy for precise ablation, and 3) Electroporation (Pulsed Field Ablation), a non-thermal technique that selectively targets cardiac tissue with electrical pulses. These methods have shown efficacy in recent studies and are gaining traction as effective treatments for AF.

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Procedure

Ablation Techniques for Atrial Fibrillation (RECONFIRM Trial)

N/A

Recruiting

Led By Sanjiv Narayan, MD, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Age >21 years

Reported incidence of at least two documented episodes of symptomatic paroxysmal or persistent atrial fibrillation (AF) during the 3 months preceding trial entry (at least one episode documented by 12-lead ECG or ECG rhythm strip). Ideally, patients will have implanted continuous ECG recorders in place for >30 days prior to the procedure to document AF episodes and percentage of time in AF ("burden") prior to ablation

Must not have

Non-Stable Coronary Disease: Stable/unstable angina or ongoing myocardial ischemia; Myocardial infarction (MI) within the past 3 months

Anti-Coagulation Contraindicated: Contraindication to Heparin; Contraindication to Warfarin or other novel oral anticoagulants (e.g., dabigatran, rivaroxabanm apixaban); History of significant bleeding abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods of treating atrial fibrillation: one using a special technique to find specific problem areas in the heart and one without it. It targets patients whose condition hasn't improved with medication. The special technique aims to make the treatment more precise and effective.

Who is the study for?

Adults over 21 with symptomatic atrial fibrillation, stable on medical therapy for 3+ months, and a left atrial diameter ≤5.5cm. Must have had at least two episodes of AF in the last three months and be refractory to one anti-arrhythmic medication. Participants need to agree to anticoagulation post-procedure and not be pregnant or planning pregnancy.

What is being tested?

The study is testing if adding FIRM (Focal Impulse and Rotor Modulation) to conventional PVI (Pulmonary Vein Isolation) is safer and more effective for treating atrial fibrillation than PVI alone. Patients are randomly assigned to either treatment group.

What are the potential side effects?

Potential side effects include risks associated with ablation procedures such as bleeding, infection, damage to heart structures, blood clots leading to stroke or other issues, arrhythmias, reactions from anesthesia or contrast media used during imaging.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 21 years.

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I have had at least two episodes of AF in the last 3 months, confirmed by an ECG.

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My left atrial diameter is 5.5cm or less, confirmed by a heart scan.

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My heart condition didn't improve after taking a specific heart medication.

Exclusion Criteria

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

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I have had a heart attack in the last 3 months or have ongoing heart issues.

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I cannot take blood thinners due to allergies or bleeding issues.

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I have had a blood clot in my heart or lungs recently.

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My electrolyte levels are stable enough for an ablation procedure.

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I have a history of significant blood clotting problems.

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I have a serious lung condition or another illness that makes anesthesia risky for me.

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

Long term success

Secondary study objectives

Adverse Events

Healthcare Utilization

Long-term freedom from AF/AT

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FIRM-guided ablation plus PVIExperimental Treatment1 Intervention

These patients will be treated by ablation of patient-specific rotors and focal sources (FIRM). Conventional ablation (PVI) will then be performed as part of the standard of care procedure.

Group II: Conventional AF Ablation with PVIActive Control1 Intervention

These patients will be treated by conventional AF ablation by pulmonary vein isolation (PVI) alone.

0 / 10Eligibility 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 rate control and rhythm control strategies. Rate control uses medications like beta blockers, calcium channel blockers, and digoxin to slow the heart rate by blocking the atrioventricular (AV) node. Rhythm control involves restoring and maintaining normal heart rhythm through cardioversion and antiarrhythmic drugs. FIRM-guided ablation, combined with pulmonary vein isolation (PVI), targets specific areas in the atria that sustain AF in addition to isolating the pulmonary veins, which are common sources of erratic electrical signals. This combined approach is important because it addresses both the triggers and sustaining mechanisms of AF, potentially leading to better long-term outcomes for patients.

Focal impulse and rotor modulation guided ablation versus pulmonary vein isolation for atrial fibrillation: A meta-analysis of head-to-head comparative studies.Rotor mapping: black box or very simple? The FIRM approach.