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Clinical trial Recruiting at 5 sites Interventional Ages 18 and up

Arrhythmia mapping with a paddle-shaped multi-electrode catheter

Official title: Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter (an Exploratory Investigation)

Run by Biosense Webster, Inc. · NCT07116525 · Data updated 2026-11-12

This test uses a new high-density multi-electrode catheter to see if it can safely map atrial and ventricular arrhythmias in adults having catheter mapping and ablation.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment90 (estimated)
SponsorBiosense Webster, Inc.
Industry-sponsored
Locations5 sites (Bruges and 4 other locations)
StatusRecruiting
StartedSeptember 15, 2025
Main results expectedFebruary 7, 2027
Study endsFebruary 7, 2027
Registry record updatedNovember 4, 2026
Trial IDNCT07116525 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) scheduled for clinically indicated catheter mapping and ablation for ventricular tachycardia, premature ventricular complexes, atrial tachycardia, or atrial fibrillation with documentation of the arrhythmia within the past 12 months are ideal candidates.

Probably not a fit

Patients whose arrhythmias are caused by reversible noncardiac factors or electrolyte/thyroid imbalance, and those who require left atrial-specific procedures, are unlikely to benefit from this mapping device.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with atrial or ventricular arrhythmias who are scheduled for clinically indicated catheter mapping and ablation will have the investigational paddle-shaped, high-density multi-electrode catheter used during their procedure to create electrical maps of the heart. The study will record whether the catheter can produce usable maps (feasibility) and capture any device- or procedure-related adverse events (safety). Eligible participants must have had a documented episode of the target arrhythmia within the prior 12 months and be able to consent and complete follow-up. Patients with arrhythmias due to reversible causes or those requiring left atrial procedures are excluded.

Why it matters

Potential benefit: If successful, the catheter could provide faster and more detailed electrical maps to better guide ablation and potentially improve procedural success and safety.

How similar studies have gone: Other high-density multi-electrode mapping systems have been used successfully to produce detailed cardiac maps and speed mapping, though the specific paddle-shaped catheter design under test is a newer configuration.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • AZ Sint-Jan
    Bruges, Belgium     Recruiting
  • Jessa Ziekenhuis
    Hasselt, Belgium     Recruiting
  • CHU de Bordeaux - Hospital Haut-Leveque
    Pessac, France     Recruiting
  • Chu Rennes Hopital Pontchaillou
    Rennes, France     Recruiting
  • Vilnius University Hospital Santaros Clinics
    Vilnius, Lithuania     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.