AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation

Ablacon

Status: Completed

Conditions: Atrial Fibrillation, Persistent; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases

Treatments: Device: Electrographic Flow™ (EGF) mapping and ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT05481359

CP-003

Details and patient eligibility

About

This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.

Full description

The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of Electrographic Flow (EGF™) mapping with Ablamap® Software for its intended use in a real-world setting. Specifically, we will evaluate the ability of EGF mapping to identify sources of atrial fibrillation (AF) and guide ablation therapy in patients with atrial fibrillation. This registry will enroll up to 100 subjects. Subjects that present with AF and meet inclusion/exclusion criteria will be eligible for enrollment.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Subjects who are not candidates for cardiac ablation procedures.
2. Pregnant or nursing.
3. Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.

Trial design

25 participants in 1 patient group

Electrographic Flow™ guided ablation therapy

Description:

In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by EGF mapping.

Treatment:

Device: Electrographic Flow™ (EGF) mapping and ablation