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Freezing heart rhythms: could a cold balloon tame AFib in failing hearts?

NCT ID NCT04461691

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a procedure called cryoballoon ablation in 1,420 people with atrial fibrillation (an irregular heartbeat) and severe heart failure. The goal was to see if freezing the veins that trigger the irregular rhythm could reduce recurrence of the heart rhythm problem and improve safety. The approach is already used in people with normal heart function, and this study aimed to see if it works as well in those with heart failure.

What this could mean

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

Active substance
Cryoballoon ablation (a procedure that uses freezing to isolate pulmonary veins)
What this could lead to
If successful, this could offer a safe and effective treatment option for atrial fibrillation in patients with severe heart failure, potentially reducing symptoms and hospitalizations.
What could go wrong
This is a completed study, but results are not yet widely known. The procedure carries risks like stroke, bleeding, or nerve injury, and may not work for everyone.

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

1,420 people

The number who actually took part.

Started

Jan 2018

Finished

Aug 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 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: * Symptomatic paroxysmal or persistent atrial fibrillation * Patients with severe heart failure (LVEF ≤40%, assigned to heart failure group) * Patients with normal cardiac function (assigned to control group) * Age \> 18 years * Consent capacity Exclusion Criteria: * Age under 18 years * Pregnancy * Lack of consent capacity

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Conditions

The condition(s) this trial relates to.

atrial fibrillation heart failure

As listed by the trial registrant

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

Atrial fibrillation Cryoballon ablation Heart failure

Contacts and locations

Locations

  • St. Josefs-Hospital Wiesbaden GmbH

    Wiesbaden, 65189, Germany

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