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New heart mapping catheter put to the test

NCT ID NCT07116525

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 01, 2026 · Updated 8 times

Summary

This study is testing a new paddle-shaped catheter designed to map the heart's electrical signals in people with various heart rhythm disorders like atrial fibrillation and ventricular tachycardia. The device has many sensors to create a detailed map of the heart's chambers. The goal is to see if it is safe and can successfully map the heart without needing another catheter. Sixty participants will be enrolled, and researchers will track any serious side effects within a week of the procedure.

What this could mean

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

Active substance
Paddle-shaped, high-density, multi-electrode mapping catheter
What this could lead to
If successful, this could lead to a new tool that helps doctors more accurately map heart rhythm problems, potentially improving the precision of ablation procedures.
What could go wrong
This is an early feasibility study with only 60 participants, so results may not apply to everyone. The main goal is safety and basic function, not yet proving better patient outcomes.

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 90 people

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

Started

Sep 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Diagnosed with and candidate for clinically indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation (participant having undergone a previous ablation procedure may be included) * At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months prior to enrollment * Age 18 years or older * Signed Patient Informed Consent Form (ICF) * Able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: * Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause * Patients requiring left atrial procedures: left atrial size greater than (\>) 55 millimeter (mm) * Left ventricular ejection fraction(LVEF) less than or equal to (\<=) 25 percentage (%) for participants with ventricular arrhythmia * LVEF \<= 40% for participants with atrial arrhythmia * Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter * Contraindication to anticoagulation (that is, heparin, warfarin, dabigatran) * History of blood clotting or bleeding abnormalities (example hypercoagulable state) * Myocardial infarction within the past 2 months (60 days) * Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 12 months (365 days) * Uncontrolled heart failure or New York heart association (NYHA) function class IV * Implanted with a pacemaker or intracardiac cardiac defibrillator or appendage closure device within the past 6 weeks (42 days) * Patients with known untreatable allergy to contrast media * Active illness or active systemic infection or sepsis * Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study * Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) * Participants that currently have Impella or equivalent devices on the procedure date or up to 7 days prior * Any cardiac surgery within the past 60 days (2 months) (includes percutaneous coronary intervention \[PCI\]) * Atrial septal closure within the past 6 weeks (42 days) * Presence of a condition that precludes vascular access * Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation * Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being * Concurrent enrollment in an investigational study evaluating another device or drug

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    5 sites in 3 countries. 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

  • AZ Sint-Jan

    RECRUITING

    Bruges, 8000, Belgium

  • CHU de Bordeaux - Hospital Haut-Leveque

    RECRUITING

    Pessac, 33604, France

  • Chu Rennes Hopital Pontchaillou

    RECRUITING

    Rennes, 35033, France

  • Jessa Ziekenhuis

    RECRUITING

    Hasselt, 3500, Belgium

  • Vilnius University Hospital Santaros Clinics

    RECRUITING

    Vilnius, 08406, Lithuania

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