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AFib ablation study halted early – what it means for patients

NCT ID NCT06364215

Disease control Sponsor: Jorge Romero Source: ClinicalTrials.gov ↗

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two types of heart ablation for people with paroxysmal atrial fibrillation (AFib). One group received standard pulmonary vein isolation, while the other also had the back wall of the left atrium isolated. Both used a newer technique called pulsed-field ablation. The trial was terminated early, so we don't have full results on which approach works better or is safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pulsed-field ablation (device procedure)
What this could lead to
If successful, this could show that adding posterior wall isolation to standard ablation reduces atrial fibrillation recurrence more than standard ablation alone.
What could go wrong
The trial was terminated, so no definitive conclusions can be drawn. It was also a relatively small, single-center study, and results may not apply to all patients.

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

198 people

The number who actually took part.

Started

Oct 2024

Finished

Nov 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

21 to 90 years

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: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age 21-90 years. 4. Symptomatic PAF whether failed AAD or not. 5. At least one symptomatic episode of PAF lasting \<7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment. 6. Patients undergoing first time ablation for AF. 7. Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure. Exclusion Criteria: 1. Persistent atrial fibrillation (PeAF) (\> 7 days in duration). 2. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause. 3. Previous surgical or catheter ablation of AF. 4. Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve. 5. Left atrium anteroposterior (LA AP) diameter \>55 mm or indexed left atrium (LA) volume \>48 ml/m2. 6. Contraindications to oral or systemic anticoagulation. 7. Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months. 8. Previous myocardial infarction or percutaneous coronary intervention within the past 2 months. 9. Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days). 10. Pregnancy. 11. History of PV stenosis. 12. History of severe pulmonary hypertension. 13. History of diaphragmatic paresis or hemi-paresis. 14. History of heart transplantation. 15. History of blood clotting or bleeding abnormalities. 16. Life expectancy of less than 12 months. 17. Presence of intracardiac thrombus. 18. Complex congenital heart disease, including tetralogy of Fallot, ventricular septal defects, Ebstein's anomaly, systemic right ventricle, and transposition of the great arteries. 19. Intracardiac or vascular abnormalities that preclude adequate catheter introduction or manipulation within the LA. 20. Pacing dependent patients. 21. Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma). 22. Active systemic infection. 23. Participation in any other AF-related randomized clinical trial.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (paroxysmal)

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Corewell Health William Beaumont Hospital

    Royal Oak, Michigan, 48073, United States

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901, United States

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • HCA Florida Mercy Hospital

    Miami, Florida, 33133, United States

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805, United States

  • Maine Medical Center

    Portland, Maine, 04102, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Methodist Hospital-San Antonio

    San Antonio, Texas, 78229, United States

  • North Shore University Hospital, Northwell Health

    Manhasset, New York, 11030, United States

  • Orion Medical

    Houston, Texas, 77034, United States

  • St. Luke's Boise Medical Center

    Boise, Idaho, 83712, United States

  • St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's

    Jacksonville, Florida, 32204, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

  • Trident Medical Center

    Charleston, South Carolina, 29406, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

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