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 amiodarone, sotalol, dofetilide, flecainide, and propafenone can have side effects including thyroid dysfunction, pulmonary toxicity, proarrhythmia, and liver toxicity. Catheter ablation, particularly pulmonary vein isolation (PVI), is another treatment option. While generally effective, it carries risks such as bleeding, infection, cardiac tamponade, and pulmonary vein stenosis. The OPTIMA ablation trial, which uses patient-specific modeling to target pro-arrhythmic sites, aims to improve the efficacy of PVI but still shares these procedural risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Atrial Fibrillation, including anti-arrhythmic drugs and catheter ablation techniques. Notably, the HeartLight laser balloon ablation system was approved in 2016 for treating paroxysmal AF, which involves advanced imaging for precise ablation. While specific FDA approvals for patient-specific modeling and LGE-MRI-based ablation like the OPTIMA trial are not detailed, the trend towards personalized and image-guided ablation therapies is evident in recent advancements.

What other types of research exist?

Promising novel alternatives to OPTIMA ablation for AF patients include: 1) Cryoballoon ablation, which uses extreme cold to isolate pulmonary veins and has shown comparable efficacy to radiofrequency ablation. 2) Laser balloon ablation, which uses laser energy for precise ablation and has demonstrated good outcomes in clinical studies. 3) Hybrid surgical-catheter ablation, combining minimally invasive surgery with catheter ablation for persistent AF. 4) New antiarrhythmic drugs like vernakalant, which has shown effectiveness in converting AF to sinus rhythm. 5) Advanced monitoring technologies such as implantable loop recorders and wearable ECG devices for early detection and management of AF episodes.

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Procedure

PVI vs PVI + OPTIMA Ablation for Atrial Fibrillation (OPTIMA Trial)

N/A

Recruiting

Led By David Spragg, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Eligible patients must be at least 18 years old at the time of enrollment.

A Pre-Op cardiac MRI including LGE in sinus rhythm must be performed prior to ablation and patient should be capable of undergoing cardioversion and cardiac MRI.

Must not have

Inability to get MRI in sinus rhythm.

Patient is currently not on anticoagulation and has significant contraindications to initiate systemic anticoagulation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new method called OPTIMA for treating persistent atrial fibrillation (AF). It aims to better target problem areas in the heart to improve treatment success for patients who haven't responded well to other treatments.

Who is the study for?

This trial is for adults over 18 with persistent atrial fibrillation who are referred for catheter ablation, can undergo MRI scans, and are on or can start anticoagulation therapy. It's not suitable for pregnant women, those over 300 lbs, with severe kidney issues (GFR <30), no evidence of left atrial fibrosis on MRI, or have had AF for more than 3 years.

What is being tested?

The study compares two procedures in treating persistent atrial fibrillation: the standard Pulmonary Vein Isolation (PVI) and PVI combined with OPTIMA-guided catheter ablation. Patients will be randomly assigned to one of these treatments and followed up at intervals to assess effectiveness and any complications.

What are the potential side effects?

Potential side effects include risks associated with cardiac ablation such as bleeding, infection at the catheter insertion site, damage to blood vessels or heart structures, arrhythmias during recovery period, reactions to anesthesia or contrast used in imaging.

Eligibility Criteria

Inclusion Criteria

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

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I am at least 18 years old.

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I can have a heart MRI and cardioversion before my heart procedure.

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I was referred to Johns Hopkins for a special heart rhythm correction procedure.

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I am currently on blood thinners or can start taking them if needed.

Exclusion Criteria

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

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I cannot have an MRI due to my irregular heartbeat.

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I am not on blood thinners and cannot start them due to health reasons.

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My kidney function is good enough for an MRI with contrast.

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I have had atrial fibrillation for more than 3 years.

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I have had a surgical maze procedure before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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 atrial arrhythmias (>30s)

Secondary study objectives

Change in AF burden

Freedom from major complications

Percent participants with 70% or more reduction in AF burden

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: OPTIMA AblationExperimental Treatment1 Intervention

Patients in this arm will receive standard PVI ablation and supplemental ablation of reentrant driver sites identified by OPTIMA analysis as sites likely supportive of persistent atrial fibrillation.

Group II: Standard Ablation (PVI)Active Control1 Intervention

Patients in this arm will receive standard ablation for atrial fibrillation (wide-area circumferential ablation to achieve pulmonary vein isolation \[PVI\]).

0 / 9Eligibility 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

The most common treatments for Atrial Fibrillation (AF) include catheter ablation, antiarrhythmic drugs, and anticoagulation therapy. Catheter ablation, particularly Pulmonary Vein Isolation (PVI), targets the electrical pathways in the heart to prevent abnormal rhythms. The OPTIMA ablation approach enhances this by using patient-specific modeling based on LGE-MRI to identify and target pro-arrhythmic sites, potentially improving outcomes. Antiarrhythmic drugs work by modifying the electrical signals in the heart to maintain a normal rhythm, while anticoagulation therapy reduces the risk of stroke by preventing blood clots. These treatments are crucial for managing symptoms, reducing complications, and improving the quality of life for AF patients.

Reinforcement Learning to Improve Image-Guidance of Ablation Therapy for Atrial Fibrillation.An atrial fibrosis-based approach for atrial fibrillation ablation.Virtual electrophysiological study of atrial fibrillation in fibrotic remodeling.