PVI vs PVI + OPTIMA Ablation for Atrial Fibrillation
(OPTIMA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Must be taking: Anticoagulants
Disqualifiers: Pregnancy, Obesity, Low GFR, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
16789How 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.
24101112Eligibility Criteria
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
I am at least 18 years old.
I understand and can agree to the study's procedures and risks.
The MRI scan should show signs of scarring in the left atrium.
+3 more
Exclusion Criteria
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 cannot have an MRI due to my irregular heartbeat.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-procedure Assessment
Patients undergo pre-procedure imaging and rhythm assessment, including LGE-MRI and Ziopatch
1 week
1 visit (in-person)
Ablation Procedure
Patients undergo either standard PVI or PVI+OPTIMA ablation for atrial fibrillation
1 day
1 visit (in-person, hospital stay)
Post-procedure Monitoring
Overnight monitoring in the hospital following ablation
1 day
1 visit (in-person, hospital stay)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including rhythm assessment with Ziopatch at 3, 6, and 12 months
12 months
3 visits (in-person)
Participant Groups
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.
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 \[PVI\]).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins HospitalBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Individually tailored vs. standardized substrate modification during radiofrequency catheter ablation for atrial fibrillation: a randomized study. [2019]This randomized single-centre study sought to compare the efficacy and safety of pulmonary vein isolation (PVI) plus voltage-guided ablation vs. PVI with or without linear ablation depending on the type of atrial fibrillation (AF).
Duty-cycled multi-electrode radiofrequency vs. conventional irrigated point-by-point radiofrequency ablation for recurrent atrial fibrillation: comparative 3-year data. [2022]Pulmonary vein isolation (PVI) is an accepted treatment to relieve symptoms in patients with atrial fibrillation (AF). We studied 3 year outcome after PVI guided by duty-cycled multi-electrode radiofrequency (RF) ablation (pulmonary vein ablation catheter, PVAC) and provided comparative data to outcome after conventional PVI (CPVI) using mapping with irrigated, point-per-point RF ablation.
A prospective, randomized comparison of modified pulmonary vein isolation versus conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation. [2012]Pulmonary vein isolation (PVI) is the primary ablation therapy in patients with atrial fibrillation (AF). We hypothesized that high dominant frequency (DF) sites (AF nests during sinus rhythm [SR]) adjacent to the PV ostia are associated with the atrial substrate that maintains AF, and PVI incorporating the high-frequency AF nests may have a higher efficacy.
Radiofrequency Ablation of Atrial Fibrillation: Nonrandomized Comparison of Circular versus Point-by-Point "Smart" Ablation for Achieving Circumferential Pulmonary Vein Isolation and Curing Arrhythmic Symptoms. [2022]Pulmonary vein isolation (PVI) with radiofrequency (RF) ablation is now standard care for atrial fibrillation (AF). New improvements in PVI techniques include use of catheters that measure contact-force and circular ablation catheters. These techniques have not been compared.
Circumferential pulmonary vein isolation with second-generation multipolar catheter in patients with paroxysmal or persistent atrial fibrillation: Procedural and one-year follow-up results. [2018]There is a lack of procedural and follow-up data on pulmonary vein isolation (PVI) with the second-generation pulmonary vein ablation catheter® (PVAC Gold) in patients with atrial fibrillation (AF). This study provides data on PVI procedures and 1-year follow-up results with PVAC Gold in patients with AF treated in clinical practice.
Efficacy of extended antrum ablation based on substrate mapping plus pulmonary vein isolation in the treatment of atrial fibrillation. [2022]Pulmonary vein isolation (PVI) technique has become the cornerstone of atrial fibrillation (AF) catheter ablation. The objective of this study was to assess the efficacy and safety of extended antrum ablation based on electrophysiological substrate mapping plus PVI in AF patients who underwent cryoballoon ablation.
Pulmonary vein isolation for the maintenance of sinus rhythm in patients with atrial fibrillation: a meta-analysis of randomized, controlled trials. [2022]Catheter ablation is an established yet evolving nonpharmacologic intervention for the maintenance of sinus rhythm in patients with atrial fibrillation (AF). The efficacy and safety of pulmonary vein isolation (PVI) compared with medical therapy remain in question.
Outcomes of adjunct posterior wall isolation in atrial fibrillation patients with cardiac implantable electronic devices. [2023]Although pulmonary vein isolation (PVI) remains the cornerstone of catheter ablation of atrial fibrillation (AF), several studies have illustrated clinical benefits associated with PVI with posterior wall isolation (PWI).
Tailored Target Ablation Index Guided Pulmonary Vein Isolation in Treating Paroxysmal Atrial Fibrillation: A Single Center Randomized Study in Asian Population (AI-Asian-I). [2022]To evaluate the efficacy and safety of lower ablation indexes (AI) guided pulmonary vein isolation (PVI) in treating paroxysmal atrial fibrillation (AF).
Innovations in atrial fibrillation ablation. [2023]Catheter-based ablation to perform pulmonary vein isolation (PVI) has established itself as a mainstay in the rhythm control strategy of atrial fibrillation. This review article aims to provide an overview of recent advances in atrial fibrillation ablation technology.
Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation. [2016]Pulmonary vein isolation (PVI) as a cornerstone for catheter ablation of atrial fibrillation (AF) remains a complex and time-consuming procedure.
Focal Impulse and Rotor Modulation Ablation vs. Pulmonary Vein isolation for the treatment of paroxysmal Atrial Fibrillation: results from the FIRMAP AF study. [2022]Pulmonary vein isolation (PVI) is the gold standard for atrial fibrillation (AF) ablation. Recently, catheter ablation targeting rotors or focal sources has been developed for treatment of AF. This study sought to compare the safety and effectiveness of Focal Impulse and Rotor Modulation (FIRM)-guided ablation as the sole ablative strategy with PVI in patients with paroxysmal AF.