PVI vs PVI + OPTIMA Ablation for Atrial Fibrillation
(OPTIMA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should be on systemic anticoagulation (blood thinners) or have no issues starting it.
Is PVI with OPTIMA ablation safe for humans?
Research studies have evaluated the safety of pulmonary vein isolation (PVI) with various techniques, including voltage-guided and ablation index-guided methods, in treating atrial fibrillation. These studies generally suggest that PVI, whether alone or with additional techniques, is considered safe for humans.12345
How is the PVI + OPTIMA ablation treatment different from other treatments for atrial fibrillation?
The PVI + OPTIMA ablation treatment is unique because it combines standard pulmonary vein isolation (PVI) with OPTIMA-guided catheter ablation, which may target specific areas in the heart more precisely. This approach aims to improve the effectiveness of the treatment by addressing additional sources of atrial fibrillation beyond the pulmonary veins.678910
What data supports the effectiveness of the treatment OPTIMA-guided catheter ablation for atrial fibrillation?
Research shows that pulmonary vein isolation (PVI) is a standard and effective treatment for atrial fibrillation, and improvements in PVI techniques, such as using advanced catheters, have been shown to enhance outcomes. Studies comparing different PVI methods suggest that incorporating additional techniques, like voltage-guided ablation, may improve the effectiveness of the treatment.27101112
Who Is on the Research Team?
David Spragg, MD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-procedure Assessment
Patients undergo pre-procedure imaging and rhythm assessment, including LGE-MRI and Ziopatch
Ablation Procedure
Patients undergo either standard PVI or PVI+OPTIMA ablation for atrial fibrillation
Post-procedure Monitoring
Overnight monitoring in the hospital following ablation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including rhythm assessment with Ziopatch at 3, 6, and 12 months
What Are the Treatments Tested in This Trial?
Interventions
- OPTIMA-guided catheter ablation
- Standard PVI
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator