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A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter | Clinical Trials | Clareo Health

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A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

Clinical Evaluation of Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

NCT05373862•Biosense Webster, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 (participants 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 of enrollment
•Signed participants Informed Consent Form (ICF)
•Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria

•Diagnosed with an arrhythmia requiring epicardial mapping
•Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause
•Atrial arrhythmias: participants with a left atrial size greater than (\>) 55 millimeters (mm)
•Left Ventricular Ejection Fraction (LVEF) less than or equal to (\<=) 25 percent (%) 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)
+13 more criteria

Locations (4)

Onze-Lieve-Vrouw (OLV) Ziekenhuis

Aalst, Belgium

Universitair Ziekenhuis (UZ) Brussel

Brussels, Belgium

University Hospital Center Split

Split, Croatia

Ospedale Generale Regionale Francesco Miulli (F. Miulli)

Acquaviva delle Fonti, Italy

Key Dates

Start Date

July 29, 2022

Primary Completion Date

February 20, 2023

Completion Date

February 20, 2023

Last Updated

March 3, 2025

Enrollment

ACTUAL participants

Conditions

Scar-related Atrial TachycardiaPersistent Atrial FibrillationParoxysmal Atrial FibrillationVentricular TachycardiaPremature Ventricular Complex

Interventions

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

DEVICE

Medtronic Terminate AF Study

NCT03546374

Persistent Atrial FibrillationLongstanding Persistent Atrial Fibrillation

View study

RECRUITINGNA

FIH Study of PFLotus in Persistent Atrial Fibrillation

NCT07301190

Persistent Atrial Fibrillation

View study

RECRUITINGNA

Burst Stimulation for Paroxysmal Atrial Fibrillation

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

Inclusion Criteria

Exclusion Criteria

Medtronic Terminate AF Study

FIH Study of PFLotus in Persistent Atrial Fibrillation

Burst Stimulation for Paroxysmal Atrial Fibrillation

Hybrid Ablation of Atrial Fibrillation in Heart Failure

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

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