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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 belowSelect...
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:Select...
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
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 \[PVI\]).
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.
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.
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,929 Previous Clinical Trials
47,765,027 Total Patients Enrolled
46 Trials studying Atrial Fibrillation
539,593 Patients Enrolled for Atrial Fibrillation
Johns Hopkins UniversityLead Sponsor
2,323 Previous Clinical Trials
14,874,100 Total Patients Enrolled
13 Trials studying Atrial Fibrillation
11,658 Patients Enrolled for Atrial Fibrillation
David Spragg, MDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
369 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
369 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 18 years old.I am not pregnant, as the study requires an MRI with a contrast agent not safe during pregnancy.You weigh more than 300 pounds and cannot have an MRI scan.I understand and can agree to the study's procedures and risks.I cannot have an MRI due to my irregular heartbeat.I am not on blood thinners and cannot start them due to health reasons.My kidney function is good enough for an MRI with contrast.The MRI scan should show signs of scarring in the left atrium.My MRI shows no left atrial fibrosis.I was referred to Johns Hopkins for a special heart rhythm correction procedure.I can have a heart MRI and cardioversion before my heart procedure.I am currently on blood thinners or can start taking them if needed.I cannot undergo AF ablation.I have had atrial fibrillation for more than 3 years.I have had a surgical maze procedure before.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Ablation (PVI)
- Group 2: OPTIMA Ablation
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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