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New ablation technique tested against standard in heart failure patients

NCT ID NCT07181291

Disease control Sponsor: St. Josefs-Hospital Wiesbaden GmbH 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of ablation (pulsed-field vs cryoballoon) for treating atrial fibrillation in people with heart failure and reduced pumping function. Researchers looked back at 700 patients who had their first ablation to see which method works better and is safer. The goal is to find out if the newer pulsed-field method is as good as the standard cryoballoon method.

What this could mean

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

Active substance
pulmonary vein isolation (PVI) procedure
What this could lead to
If successful, this could show that pulsed-field ablation is as safe and effective as cryoballoon ablation for controlling atrial fibrillation in heart failure patients.
What could go wrong
This is a retrospective study, not a randomized trial, so results may be biased. The non-inferiority margin is wide, and the study may not prove one method is better.

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.

Participants

700 people

The number who actually took part.

Started

Sep 2025

Finished

Feb 2026

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.

Who is studied

Patients with atrial fibrillation and heart failure (LVEF ≤ 40%)

Ages

18 to 99 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. Patients with paroxysmal or persistent AF and echocardiographically confirmed HFrEF (LVEF ≤ 40%) 2. Patients who underwent their first PVI using pulsed field or cryoballoon ablation as part of clinical routine 3. Patients with regular follow-up via 12-lead ECG or Holter ECG following PVI 4. Patients with at least three months of follow-up Exclusion Criteria: 1. Patients who did not undergo pulsed field or cryoballoon ablation for first-time PVI 2. Patients with LVEF \> 40% 3. Patients who declined the use of their data during initial collection

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Conditions

The condition(s) this trial relates to.

atrial fibrillation heart failure systolic heart failure

As listed by the trial registrant

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

Atrial fibrillation Heart failure with reduced ejection fraction

Contacts and locations

Locations

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf, Germany

  • Evangelisches Krankenhaus Hagen-Haspe

    Hagen, Germany

  • Kerckhoff-Klinik Bad Nauheim

    Bad Nauheim, Germany

  • Klinikum Fürth

    Fürth, Germany

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Montreal Heart Institute

    Montreal, Quebec, Canada

  • St. Josefs-Hospital Wiesbaden

    Wiesbaden, Germany

  • Universitätsklinikum Frankfurt am Main

    Frankfurt am Main, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg-Eppendorf, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, Germany

  • Vancouver General Hospital

    Vancouver, British Columbia, Canada

  • Vivantes Klinikum am Urban

    Berlin, Germany

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