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

Ablacon

Status: Completed

Conditions: Atrial Fibrillation, Persistent

Treatments: Device: Ablamap Software

Study type: Interventional

Funder types: Industry

Identifiers

NCT04473963

CP-001/002

Details and patient eligibility

About

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

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

EGF-Guided Ablation Therapy

Experimental group

Description:

Subjects randomized to "therapy" will be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software).

Treatment:

Device: Ablamap Software

Control - No Ablation Therapy

No Intervention group

Description:

Subjects randomized to "control" will not be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software). The subjects will be cardioverted (as applicable) and the procedure will end.