Novel Cardiac Signal Processing System

NCT ID: NCT04112433

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-12
• Study Completion Date: 2022-01-29

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.

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

Conditions

Cardiac Arrhythmia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

PURE EP 2

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioSig Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

St. David's Medical Center

Austin, Texas, United States

Countries

United States

References

Padmanabhan D, Sugrue A, Vaidya V, Witt C, Yasin O, Naksuk N, Killu A, Foxall T, Drakulic BS, Venkatachalam KL, Asirvatham SJ. Incremental benefit of a novel signal recording system during mapping and ablation. Europace. 2021 Jan 27;23(1):130-138. doi: 10.1093/europace/euaa194.

Reference Type: DERIVED

PMID: 33094311 (View on PubMed)

Other Identifiers

PURE EP 2.0

Identifier Type: -

Identifier Source: org_study_id