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Novel Cardiac Signal Processing System

NCT04112433 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2022-02-11

No results posted yet for this study

Summary

This study is designed to collect parallel intracardiac signal data during pre-defined periods of clinical interest from the PURE EP system and the existing signal recording and mapping systems.

The collected signals will then undergo BLINDED, CONTROLLED evaluation by unbiased electrophysiologist reviewer(s) to determine whether the PURE EP signals provides additional or clearer diagnostic information.

Conditions

  • Cardiac Arrhythmia

Interventions

DEVICE

PURE EP 2

Enrolled patients receiving cardiac ablation treatment using the current standard of care with additional monitoring and intracardiac electrogram signal collection via the PURE EP 2 system.

Sponsors & Collaborators

  • BioSig Technologies, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2021-07-20
Completion
2022-01-29
FDA Device
Yes

Countries

  • United States

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 NCT04112433 on ClinicalTrials.gov