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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

OPTIMA Trial Summary

This trial is a prospective, randomized clinical trial in patients undergoing ablation for symptomatic persistent AF to assess whether adding OPTIMA ablation to PVI improves freedom from AF.

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.Check my eligibility

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.See study design

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.

OPTIMA Trial 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.

OPTIMA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Freedom from atrial arrhythmias (>30s)

Secondary outcome measures

Change in AF burden

Freedom from major complications

Percent participants with 70% or more reduction in AF burden

OPTIMA 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,263 Previous Clinical Trials

14,822,965 Total Patients Enrolled

11 Trials studying Atrial Fibrillation

7,449 Patients Enrolled for Atrial Fibrillation

David Spragg, MDPrincipal InvestigatorJohns Hopkins University

2 Previous Clinical Trials

160 Total Patients Enrolled

2 Trials studying Atrial Fibrillation

160 Patients Enrolled for Atrial Fibrillation

Media Library

OPTIMA-guided catheter ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04101539 — N/A

Atrial Fibrillation Research Study Groups: Standard Ablation (PVI), OPTIMA Ablation

OPTIMA-guided catheter ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04101539 — N/A

Atrial Fibrillation Clinical Trial 2023: OPTIMA-guided catheter ablation Highlights & Side Effects. Trial Name: NCT04101539 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the sample size being utilized in this medical study?

"Indeed, clinicaltrials.gov displays that this study is currently enrolling volunteers. This trial was published on September 1st 2019 and has been revised as recently as 9/26/2022. 200 individuals across one medical site are required to fulfill the enrolment goals of this research project."

Answered by AI

Are there any openings for participants in this trial currently?

"According to clinicaltrials.gov, this trial is in need of participants and has been since September 1st 2019. The study was most recently updated on the 26th of September 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Pulmonary Vein Isolation to Pulmonary Vein Isolation + OPTIMA Ablation in Patients Undergoing Ablation for Atrial Fibrillation

2019. "Comparing Pulmonary Vein Isolation to Pulmonary Vein Isolation + OPTIMA Ablation in Patients Undergoing Ablation for Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04101539.