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New ablation technique aims to zap heart flutter with less radiation and greater precision

NCT ID NCT04678258

Disease control Sponsor: Klinikum-Fuerth Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 trial tests a new way to treat typical atrial flutter, a heart rhythm problem. Instead of the standard linear ablation, doctors use a special catheter with tiny sensors to map and target only the high-voltage areas causing the flutter. The goal is to see if this approach is as effective as the standard method while using less radiation and fewer burns. About 100 adults with atrial flutter will be randomly assigned to one of the two techniques, and the results will be checked during the procedure and afterward.

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 (IntellaMiFi micro-sensor technology)
What this could lead to
If successful, this approach could make atrial flutter ablation faster, more precise, and radiation-free, potentially improving patient outcomes and reducing procedure time.
What could go wrong
This is a relatively small, early-stage trial comparing two techniques, so results may not apply broadly. The new method might not be as effective in the long term or could carry a risk of hidden conduction gaps.

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 106 people

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

Started

Nov 2020

Expected to finish

Aug 2027

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: * Typical (CTI dependent) atrial flutter documented in a standard 12 lead surface ECG * Given class I indication for curative CTI ablation according to the current guidelines * Over 18 years old * Given informed consent Exclusion Criteria: * Any contraindication for CTI ablation * Previous CTI ablation * BCB as procedural endpoint not assessable * CTI ablation conducted in association with further ablation procedures * Patients with CIED (e.g. pacemaker, ICD) * Tricuspid valve replacement * Right atrial thrombus * Pregnant or breastfeeding women * Abuse of drugs or alcohol * Age \< 18 years * Incompliance to the treatment, e.g. necessary anticoagulation * Expected survival less than one year * Inability to understand the nature and rationale of the study * Inability to take part in the follow up

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Conditions

The condition(s) this trial relates to.

atrial flutter

As listed by the trial registrant

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

Atrial flutter typical Catheter ablation Radiation exposure

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Klinikum Fuerth

    RECRUITING

    Fürth, Bavaria, 90766, Germany

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