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

NCT05373862 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-03

Study results available
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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.

Conditions

  • Scar-related Atrial Tachycardia
  • Persistent Atrial Fibrillation
  • Paroxysmal Atrial Fibrillation
  • Ventricular Tachycardia
  • Premature Ventricular Complex

Interventions

DEVICE

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

Participants scheduled to have a clinically-indicated catheter mapping and ablation procedure using globe-shaped, high-density, multi-electrode mapping catheter for management of atrial procedure (scar-related atrial tachycardia, persistent atrial fibrillation, paroxysmal atrial fibrillation) and Ventricular procedures (ventricular tachycardia, premature ventricular complex).

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • Biosense Webster, Inc. Clinical Trial · Biosense Webster, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-29
Primary Completion
2023-02-20
Completion
2023-02-20
FDA Device
Yes

Countries

  • Belgium
  • Croatia
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373862 on ClinicalTrials.gov