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Clinical Trials in Belgium / NCT07116525
Recruiting Not applicable

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

NCT07116525 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2025-09-15
Last updated
2026-09-28

Condition(s) studied

Scar-related Atrial TachycardiaPersistent Atrial FibrillationParoxysmal Atrial FibrillationVentricular TachycardiaIschemic Ventricular TachycardiaNon-ischemic Ventricular TachycardiaCardiomyopathyIdiopathic Ventricular TachycardiaPremature Ventricular Contraction

Investigational drug(s) / intervention(s)

Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter

Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter: High-density, multi-electrode mapping catheter will be used for the procedure.

Study summary

The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
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

More Biosense Webster, Inc. trials in Belgium

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07116525 on ClinicalTrials.gov ↗ ← All trials in Belgium