A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter

Launched by BIOSENSE WEBSTER, INC. · Aug 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of catheter—a small, flexible tube used by doctors to look inside the heart—to see if it is safe and works well for mapping heart rhythms. The catheter helps identify areas in the heart that cause irregular heartbeats, such as atrial fibrillation or ventricular tachycardia, which are types of abnormal heart rhythms. The goal is to improve how doctors find and treat these irregular beats during procedures that aim to restore a normal heart rhythm.

Adults diagnosed with certain irregular heartbeats who are already scheduled for a heart mapping and treatment procedure might be eligible to join. To qualify, participants must have had at least one recorded episode of their irregular heart rhythm in the past year and be 18 years or older. Those with certain heart conditions, recent heart surgeries, or other health issues may not be able to join. If you participate, you can expect the investigational catheter to be used during your planned heart procedure to help guide treatment. The study is not yet recruiting, but it aims to better understand how this new tool might help doctors treat heart rhythm problems more effectively and safely.

Gender

ALL

Eligibility 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