New heart ablation method aims to beat atrial fibrillation
NCT ID NCT04101539
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether adding a personalized, computer-model-guided ablation (OPTIMA) to the standard pulmonary vein isolation (PVI) procedure improves outcomes for people with persistent atrial fibrillation. 67 participants were randomly assigned to receive either PVI alone or PVI plus OPTIMA ablation. The goal was to see if the extra ablation could increase the chance of staying free from atrial arrhythmias for one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- catheter ablation (OPTIMA-guided)
- What this could lead to
- If successful, this approach could improve the success rate of ablation for persistent atrial fibrillation, reducing the need for repeat procedures.
- What could go wrong
- This is a small, early-phase study (67 participants) and prior similar strategies have failed to show benefit. Results may not be generalizable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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67 people
The number who actually took part.
- Started
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Sep 2019
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Eligible patients must be at least 18 years old at the time of enrollment. * Patient was referred to Johns Hopkins cardiac electrophysiology division for clinically indicated catheter ablation for persistent or long standing persistent AF either for index ablation or redo ablation. * Patient is currently on systemic anticoagulation or has no contraindication to initiate systemic anticoagulation. * Capable of undergoing informed consent. * 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. * MRI scan should show evidence of left atrial scarring. Exclusion Criteria: * Patient is not a suitable candidate for AF ablation. * Patient is currently not on anticoagulation and has significant contraindications to initiate systemic anticoagulation. * Pregnant women may not participate in the study because gadolinium MRI contrast is contraindicated in pregnancy. * Patient with Body weight more than 300 lbs as they cannot undergo MRI scans. * Patients with Glomerular Filtration Rate (GFR) \< 30 mL/min should not be enrolled in the study due to the use of intravenous gadolinium as an MRI contrast agent. * No evidence of Left Arial fibrosis in MRI scan as these images are not suitable for simulation. * Inability to get MRI in sinus rhythm. * Long standing persistent AF more than 3 years of duration. * Prior surgical maze procedure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Extra vein ablation tested to keep persistent AFib from returning
- Duel of ablation catheters: which wins for persistent AF?
- Can a new drug stop long atrial fibrillation episodes?
- Which ablation method wins for tough atrial fibrillation cases?