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New heart ablation method aims to beat atrial fibrillation

NCT ID NCT04101539

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

67 people

The number who actually took part.

Started

Sep 2019

Finished

Oct 2025

Lead sponsor

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

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

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

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