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Novel Cardiac Signal Processing System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112433
Recruitment Status : Enrolling by invitation
First Posted : October 2, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
BioSig Technologies, Inc.

Brief 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.


Condition or disease Intervention/treatment
Cardiac Arrhythmia Device: PURE EP 2

Detailed Description:

Cardiac electrophysiologists rely on the display of electrograms when performing electrophysiology (EP) studies and catheter ablations in patients with arrhythmias. To achieve effective outcomes without complications, it is vital that the recording system enables the recognition of clearly abnormal (scared myocardium) and normal electrical signals.

Current recording systems have limitations in that it can be difficult to clearly distinguish a true cardiac signal from noise or artifact. This is particularly true when pacing the heart and when ablating abnormal myocardial tissue, components of the conduction system or epicardial structures. Therefore, improvement of the fidelity of signals obtained from EP recording systems is needed to enhance identification of the most effective targets for ablation.

There are several standard electrophysiology recording systems in use today, such as the commonly used GE/Prucka CardioLab recording system ("Prucka") which would benefit from additional features in order to improve the ability to record, discriminate and analyze signals from the heart. BioSig Technologies, Inc. ("BioSig") has developed an electrophysiology signal processing system, the PURE EP™ System, which may allow electrophysiologists to better characterize arrhythmogenic tissue during ablation procedures. Specifically, the PURE EP™ System's higher sampling rate and higher dynamic range allow improved visualization of low amplitude signals, especially those temporally situated near low frequency, high amplitude signals or large high-frequency signals.

This multi-center, prospective, non-randomized, observational study will involve at least five patients undergoing elective cardiac ablation procedure for tachycardias such as atrial fibrillation, atypical atrial flutter, ischemic ventricular tachycardia, or symptomatic premature ventricular contractions (PVCs). The existing recording/mapping system clocks will be synchronized to the PURE EP clock prior to each procedure. At the beginning of the procedures, all systems will be optimized for best signal display based on the physician preference. During the ablation procedures, annotations will be captured on the PURE EP system based on pre-determined clinically relevant events defined in this protocol (example - before and after successful ablation therapy).

After the procedures, parallel signal data samples will be harvested from all the systems using the procedure annotations and the time stamps as a guide. Once the signal data is harvested, cleaned, and organized, the individual signal samples will be reviewed in a blinded, controlled fashion by a group of independent, unbiased electrophysiologist(s).

Selected signal sample sets (from the same date and time stamp) will be separated in the survey and arranged in random order. The reviewer will be asked specific and identical questions relevant to each set of signal samples, but the individual samples will be separated and randomized across a full survey containing many different signal samples from many different procedures. The signal survey will be created under the direction of the Principle Investigator. The selection of the independent EP reviewers will also be done under the direction of the Principle Investigator

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Cardiac Signal Processing System for Electrophysiology Procedures
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : July 2020

Group/Cohort Intervention/treatment
PURE EP 2 Group
Enrolled and consented patients who are indicated for and receive an elective cardiac ablation procedure using the PURE EP 2 system for monitoring and collection of intracardiac electrogram signals.
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.




Primary Outcome Measures :
  1. Safe and effective use of the PURE EP 2 system based on system specifications and recorded within the Case Report Form (CRF). [ Time Frame: Throughout the cardiac ablation procedure ]

    The primary aim of this study is to further establish the safe and effective use of the PURE EP System during cardiac ablation in the EP Laboratory in a post-market environment. The PURE EP System will be installed to run in parallel to existing mapping and recording systems already in use in the EP lab. Each system will be optimized for viewing intracardiac signals based on the physician preference. The existing systems will serve as the primary method of viewing intracardiac signals and the PURE EP system will be redundant.

    The intracardiac signals from the PURE EP system will be compared to existing recording and mapping system signals generated in real-time during each ablation procedure. The PURE EP system signals will be monitored by the physician investigator and a company clinical representative to validate the PURE EP 2 system runs as intended based on the system manual and meets expected standards for displaying signals.



Secondary Outcome Measures :
  1. Assess the quality of the PURE EP 2 intracardiac signals when compared to existing recording and mapping systems as determined by controlled survey of blinded, independent expert electrophysiology reviewers. [ Time Frame: After the collection of signal samples from at least (5) subjects and until study completion ]

    The secondary aim of this study is to assess the quality of the PURE EP intracardiac signals and the associated clinical relevance of the signals when compared to other sources of intracardiac signals. During the ablation procedures, annotations will be captured on the PURE EP system based on clinically relevant events defined in the protocol.

    After the procedure, parallel signal data samples will be harvested from all the systems using annotations and the time stamps as a guide. Once the signal data is harvested and organized, the signal samples across multiple procedures will be reviewed in a blinded, controlled fashion by 2-3 independent, unbiased expert electrophysiologist(s).

    The sample survey will be created under the direction of the PI.



Biospecimen Retention:   Samples Without DNA
bioelectrical cardiac signals


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any person indicated and consented for an elective cardiac ablation procedure who is >18 years of age.
Criteria

Inclusion Criteria:

  • Indication for cardiac ablation treatment
  • Signed informed consent

Exclusion Criteria:

  • contraindication to electrophysiology study or ablation
  • Enrollment in any other ongoing arrhythmia study protocol
  • Active Infection or sepsis
  • Pregnancy or lactation
  • < 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112433


Locations
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United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Texas
St. David's Medical Center
Austin, Texas, United States, 78758
Sponsors and Collaborators
BioSig Technologies, Inc.

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Responsible Party: BioSig Technologies, Inc.
ClinicalTrials.gov Identifier: NCT04112433    
Other Study ID Numbers: PURE EP 2.0
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Collected intracardiac signal samples will be shared with the independent electrophysiologist reviewers, other physician investigators, and possibly other study collaborators like a biostatistician and clinical research organization.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The stored intracardiac signal samples from each enrolled subject will become available for review post-procedure and indefinitely.
Access Criteria: Access to the stored intracardiac electrogram signals will be determined and managed by BioSig Technologies.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by BioSig Technologies, Inc.:
Cardiac Signal
Ablation
Signal Processing
Intracardiac Electrogram
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes