RecruitingNot ApplicableNCT07116525

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

Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter


Sponsor

Biosense Webster, Inc.

Enrollment

60 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new multi-electrode catheter used during heart rhythm procedures (electrophysiology studies) to map and guide treatment of abnormal heart rhythms — including atrial fibrillation, ventricular tachycardia, and other arrhythmias. **You may be eligible if...** - You are 18 or older - You have been diagnosed with an abnormal heart rhythm (atrial fibrillation, atrial tachycardia, ventricular tachycardia, or premature ventricular contractions) - You are already scheduled for a catheter ablation procedure - You have had at least one documented episode of your arrhythmia in the past year **You may NOT be eligible if...** - Your arrhythmia is caused by a reversible factor (e.g., thyroid disease, electrolyte imbalance) - You have a very large left atrium (over 55 mm) if undergoing left-sided procedure - Your heart pumping function is very low (ejection fraction 25% or below for ventricular arrhythmias, 40% or below for atrial arrhythmias) - You have a blood clot in the heart - You cannot take blood thinners Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

High-density, multi-electrode mapping catheter will be used for the procedure.


Locations(6)

AZ Sint-Jan

Bruges, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

Hopital les Franciscaines of Nimes

Nîmes, France

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, France

Chu Rennes Hopital Pontchaillou

Rennes, France

Vilnius University Hospital Santaros Clinics

Vilnius, Lithuania

View Full Details on ClinicalTrials.gov

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NCT07116525


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