Redo AF Sub Study (of the Pure EP 2.0 Main Study)

This study is a sub study of the Pure EP 2.0 trial. In a redo atrial fibrillation population, this study is designed to collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of interest during a redo ablation procedure. These signals are later evaluated for clinical relevance and impact on the procedure.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation Recurrent
• Intervention / Treatment: Device: Pure-EP

Detailed Description

Cardiac electrophysiologists rely on the display of electrograms when performing 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.

In a redo Atrial Fibrillation (AF) procedure, the patient had previously undergone an AF ablation procedure, but is still having AF episodes, which can be life threatening and have been shown to lead to strokes. Since the original AF procedure involved burning or freezing of myocardial tissue, this is now additional scar tissue and may cause more complex electrograms and intracardiac signals.

In this sub study, both the PURE EP™ system and the GE Cardiolab system will be running and recording signals during the entire procedure, with one of the systems displayed on the screen in the procedure room to guide the physician's decision-making. Even numbered subjects will be PURE EP™ guided and odd numbered subjected will be GE CardioLab guided. All other aspects of the procedure will proceed per standard of care. The study will be collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of interest during a redo ablation procedure.

After the physician has completed ablation treatment, matching signals of interest will be extracted from both the PURE EP™ system and the GE Cardiolab recording system as described in the main study. At a later date, a blinded electrophysiologist reviewer will evaluate the signals from both systems with a focus on tissue viability signals and the impact on the procedure. The survey results will then be compared to see the differences in clinical procedure decision-making based on the signal samples.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78758
      • St. David's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Atrial Fibrillation

Description

Inclusion Criteria:

1. Patients undergoing scheduled elective cardiac ablation procedures who have signed an informed consent
2. Patients who are > 18 years of age.
3. Patients undergoing a repeat elective cardiac AF Procedure

Exclusion Criteria:

1. A complex arrhythmia secondary to a reversible cause
2. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
3. Any cardiac surgery within the past 60 days (2 months) (includes PCI)
4. Concurrent enrollment in a study evaluating another device or drug
5. A complex arrhythmia secondary to electrolyte imbalance, thyroid disease or non-cardiac issue
6. Presence of intra-cardiac thrombus or myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation.
7. Presence of a condition that precludes vascular access.
8. Women of child baring potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation.
9. Active illness or active systemic infection or sepsis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PURE EP Guided Procedures; Redo AF procedures guided by Pure EP System during an AF Ablation	Device: Pure-EP; Advanced Signal Acquisition and Processing
Standard Recording System Guided Procedures; Redo AF procedures guided by the Standard Recording System during an AF Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the clinical procedure impact of PURE-EP signals of interest vs. a standard recording system in a Redo AF population	The signals of interest will undergo a homogenization process to remove all identifiers of the system used. At a later time, a blinded electrophysiologist reviewer will evaluate the signals for clinical relevance and procedural impact from both systems using the same Blinded Signal Assessment Form. The Blinded Assessment Form results will be compared to both each other and what was done at the procedure.	6 months

Collaborators and Investigators

• Sponsor: BioSig Technologies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): January 29, 2022

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: revision; repeat; reoccurring; redo
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Redo AF Sub Study of Pure EP 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Time Frame: The stored intracardiac signal samples from each enrolled subject will become available for review post-procedure and indefinitely.
• IPD Sharing Access Criteria: Access to the stored intracardiac electrogram signals will be determined and managed by BioSig Technologies.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• 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