FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology

Atrial Fibrillation, Persistent Clinical Trial

— FLOW-AF  

Official title:

A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW (EGF) Algorithm Technology (Ablamap Software) to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473963
• Other study ID #: CP-001/002
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: September 27, 2021

Study information

• Verified date: November 2023
• Source: Ablacon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap Software).

Description:

The objective of this study is to evaluate the reliability of the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap Software) to identify atrial fibrillation sources and guide ablation therapy in patients with persistent atrial fibrillation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias.

2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.

3. Subjects with a history of documented symptomatic, persistent or longstanding persistent atrial fibrillation < 36 months.

4. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months.

5. Treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of AF (not applicable to De Novo subjects)

Exclusion Criteria:

1. LA diameter > 5.5 cm.

2. Left ventricular ejection fraction (LVEF) < 35%.

3. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.

4. Coagulopathy, bleeding diathesis or suspected procoagulant state.

5. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.

6. Positive pregnancy test results for female patients of childbearing potential or breast feeding.

7. Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study.

8. Mitral valve stenosis and/or severe mitral regurgitation.

9. Valvular atrial fibrillation.

10. Prosthetic valves.

11. NYHA Class IV.

12. History of MI within 3 months prior to procedure.

13. Atrial septal defect (ASD) or left atrial appendage (LAA) closure device.

14. Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis or pericarditis).

15. Life expectancy < 12 months based on medical history or the medical judgement of the investigator.

16. Presence of any transvenous pacing, Implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) leads.

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Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Intervention

Device:
• Ablamap Software
Subjects will receive cardiac ablation guided by the Ablamap software. The software will identify atrial fibrillation sources to help guide ablation therapy in patients with persistent atrial fibrillation. Subjects will undergo a cardioversion post ablation, as necessary.

Locations

Country	Name	City	State
Czechia	Nemocnice Na Homolce Hospital	Prague	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
Ablacon, Inc.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint: the ability to successfully ablate AF sources identified by the EGF algorithm as measured by EGF maps of the atria pre and post ablation to determine if there is a diminished or absence of the source.	Acute procedure success defined as the ability to successfully ablate AF sources identified by the EGF algorithm	During the Procedure
Primary	Primary Safety Endpoint: Freedom from serious adverse events	Freedom from serious adverse events related to the procedure through 7 days following the randomization procedure.	7 days
Secondary	Secondary Efficacy Endpoints: Consistency of sources	Consistency of sources identified by the Ablacon EGF algorithm between the randomization procedure and any applicable subsequent EGF-guided ablation procedures as assessed by remapping of the atria and the algorithm's ability to reproduce sources identified by a previous procedure	Post procedure through 12 months
Secondary	Secondary Efficacy Endpoints: Freedom from documented episodes of AF recurrence	Freedom from documented episodes of atrial fibrillation recurrence following the blanking period (90 days post procedure through 12 months). Documentation will be from Holter recordings or EKGs.	3-12 months
Secondary	Secondary Efficacy Endpoints: Total number of EGF source ablations	Total number of EGF source ablations (count number of ablations during the procedure)	During the procedure
Secondary	Secondary Efficacy Endpoints: Total time of EGF source ablations	Total time of EGF source ablations (seconds)	During the procedure
Secondary	Secondary Efficacy Endpoints	Total fluoroscopy time (min/sec)	During the procedure
Secondary	Secondary Efficacy Endpoints	Total fluoroscopy dose (mgy)	During the procedure
Secondary	Secondary Efficacy Endpoints: Overall Procedure time	Overall Procedure time (hours/minutes)	During the procedure