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

NCT04964440 | Completed FDA Device

• 1 other identifier: Redo AF Sub Study of Pure EP 2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation Recurrent

Keywords

reoccurring; repeat; revision; redo

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PURE EP Guided Procedures

Redo AF procedures guided by Pure EP System during an AF Ablation

Device: Pure-EP

Standard Recording System Guided Procedures

Redo AF procedures guided by the Standard Recording System during an AF Ablation

Interventions

Pure-EP DEVICE

Advanced Signal Acquisition and Processing

PURE EP Guided Procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Atrial Fibrillation

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• BioSig Technologies, Inc.: lead

Study Sites (1)

St. David's Medical Center

Austin, Texas, 78758, United States

Location

Study Design

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

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 16, 2021
• Study Start: March 3, 2021
• Primary Completion: July 20, 2021
• Study Completion: January 29, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

US (1)