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A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter

NCT04983797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-07-03

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 OPTRELL Catheter for intracardiac mapping in the atria and ventricles.

Conditions

  • Scar-related Atrial Tachycardia
  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation
  • Tachycardia, Ventricular
  • Ventricular Premature Complexes

Interventions

DEVICE

OPTRELL Mapping Catheter

Participants scheduled to have a clinically-indicated catheter mapping and ablation using OPTRELL mapping catheter for the 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

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-25
Primary Completion
2021-11-04
Completion
2021-11-04
FDA Device
Yes

Countries

  • Belgium
  • Lithuania

Study Locations

More Related Trials

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 NCT04983797 on ClinicalTrials.gov