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An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias

NCT04750798 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 8000

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.

Conditions

  • Arrhythmias, Cardiac

Interventions

DEVICE

BWI Medical Device

Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.

DEVICE

Varipulse Catheter

Participants treated with Varipulse Catheter in the main study will be part of the VARIPURE sub-study. No specific intervention will be observed for this study.

DEVICE

Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Participants treated with the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter in the main study will be part of the DUACURE sub-study. No specific intervention will be observed for this study.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

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

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2036-12-31
Completion
2037-12-31
FDA Device
Yes

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Portugal
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT04750798 on ClinicalTrials.gov