Novel Cardiac Signal Processing System

NCT04112433 | Completed FDA Device

• 1 other identifier: PURE EP 2.0
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiac Arrhythmia

Keywords

Cardiac Signal; Ablation; Signal Processing; Intracardiac Electrogram; Electrophysiology; Electrogram; Signals; Cardiac; Cardiac Ablation; Atrial fibrillation; Atrial Flutter; Ventricular Tachycardia; Arrhythmias; PVC's

Outcome Measures

Primary Outcomes (1)

• Safe and effective use of the PURE EP 2 system based on system specifications and recorded within the Case Report Form (CRF).

  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.

  Throughout the cardiac ablation procedure

Secondary Outcomes (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.

  After the collection of signal samples from at least (5) subjects and until study completion

Study Arms (1)

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

Interventions

PURE EP 2 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.

PURE EP 2 Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any person indicated and consented for an elective cardiac ablation procedure who is \>18 years of age.

You may qualify if:

• Indication for cardiac ablation treatment
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• BioSig Technologies, Inc.: lead

Study Sites (3)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

St. David's Medical Center

Austin, Texas, 78758, United States

Location

Related Publications (1)

• 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.

  PMID: 33094311 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

bioelectrical cardiac signals

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: November 12, 2019
• Primary Completion: July 20, 2021
• Study Completion: January 29, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

US (3)