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 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

First listed
Aug 11, 2025
Start date
Sep 15, 2025
Status verified
Aug 2026
Primary completion
Sep 30, 2026
Completion
Feb 7, 2027

Study Design

Enrollment
90 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 mapping and ablation procedure for the management of cardiac arrhythmias. The investigational paddle-shaped, high-density, multi-electrode catheter is used for mapping purposes only.

Primary Outcome Measure

Occurrence 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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