New heart mapping catheter put to the test
NCT ID NCT07116525
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
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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
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
5 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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AZ Sint-Jan
RECRUITINGBruges, 8000, Belgium
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CHU de Bordeaux - Hospital Haut-Leveque
RECRUITINGPessac, 33604, France
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Chu Rennes Hopital Pontchaillou
RECRUITINGRennes, 35033, France
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Jessa Ziekenhuis
RECRUITINGHasselt, 3500, Belgium
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Vilnius University Hospital Santaros Clinics
RECRUITINGVilnius, 08406, Lithuania
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Do genes drive heart damage from irregular rhythms?
- Extra vein ablation tested to keep persistent AFib from returning
- Duel of ablation catheters: which wins for persistent AF?
- Pulsed electric fields take aim at irregular heartbeats
- Can heart surgery rehab move from hospital to home?