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New heart ablation method aims to stop AFib recurrence

NCT ID NCT07587541

Disease control Sponsor: University of Luebeck 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests whether a new catheter ablation system using pulsed field energy can better control persistent atrial fibrillation (AF) by targeting low-voltage areas in the heart and isolating the superior vena cava, in addition to standard pulmonary vein isolation. About 618 adults with persistent AF will be randomly assigned to different ablation strategies. The goal is to see which approach reduces the return of irregular heart rhythms at 6 and 12 months.

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

About 618 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

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 Participants must meet all the following criteria: 1. Age ≥18 years 2. Persistent AF, defined as continuous AF lasting at least 7 days 3. Indication for catheter ablation according to the latest ESC guidelines 4. Written informed consent Exclusion criteria Participants will be excluded if any of the following criteria apply: 1. Inability or unwillingness to provide informed consent 2. Continuous AF duration duration of ≥2 years 3. Documented atrial tachycardia or atrial flutter 4. Previous left atrial catheter ablation or cardiac surgery 5. Planned cardiac surgery within the first 3 months after inclusion 6. History of heart transplantation, current listing for transplantation, or planned cardiac assist device implantation 7. Severe mitral or aortic valvular disease, according to the ESC guidelines 8. Platelet count \<50,000 cells/mm³ 9. Body mass index \>45 kg/m² or \<18 kg/m² 10. Untreated thyroid dysfunction (patients may be included once hypothyroidism or hyperthyroidism is adequately treated) 11. Absolute contraindication to oral anticoagulation 12. Any comorbidity that limits life expectancy to \<1 year 13. Active systemic infection (enrolment permitted after successful treatment) 14. Women who are pregnant or breastfeeding 15. Women of childbearing potential not using highly effective contraception (PEARL Index \<1%) 16. End-stage renal disease (GFR \<15 ml/min/1.73 m2) or hepatic failure (Child Pugh C) 17. Acutely decompensated heart failure (NYHA IV), inclusion is possible only after stabilization to a NYHA functional status better than IV 18. Participation in another randomized controlled trial

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation (AF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.