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

Sponsor
Biosense Webster, Inc.
Study ID
NCT07116525
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 15, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Arrhythmia Mapping by a Paddle-shaped, High-density, Multi-electrode Mapping Catheter
    Participants scheduled to have a clinically indicated catheter mapping and ablation procedure for management of a cardiac arrhythmias will undergo catheter mapping and ablation procedure using paddle-shaped, high-density, multi-electrode mapping catheter.

Primary Outcome Measure

Incidence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping [ Time Frame: Up to 7 days post index procedure ]

Central Contacts

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