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

ConditionsScar-related Atrial Tachycardia Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation Ventricular Procedures Ventricular Tachycardia Ischemic Ventricular Tachycardia Non-ischemic Ventricular Tachycardia Cardiomyopathy Idiopathic Ventricular Tachycardia Premature Ventricular Contraction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBiosense Webster, Inc.

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

60 Participants

are divided into 1 treatment group

Sponsors and collaborators

Biosense Webster, Inc.

Lead sponsor

Source ClinicalTrials.gov