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

Completed

• Conditions: Atrial Fibrillation Recurrent
• Interventions: Device: Pure-EP

• Registration Number: NCT04964440
• Lead Sponsor: BioSig Technologies, Inc.

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.

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 Timeline

• Study Start: 2021-03-03
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-16
• Primary Completion: 2021-07-20
• Study Completion: 2022-01-29
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PURE EP Guided Procedures	Pure-EP	Redo AF procedures guided by Pure EP System during an AF Ablation

Primary Outcome Measures

Name	Time	Method
To assess the clinical procedure impact of PURE-EP signals of interest vs. a standard recording system in a Redo AF population	6 months	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.

Trial Locations

Locations (1)

St. David's Medical Center; 🇺🇸 Austin, Texas, United States