Clinical trial NCT05481359: AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation
Official title: A Post Market, Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using Electrographic Flow (EGF™) Mapping System to Guide Ablation Therapy in Patients With Atrial Fibrillation in Real-world Setting.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation, Persistent
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Keywords: Electrographic Flow Mapping
Atrial Fibrillation
Lead sponsor: Cortex
Sponsor class: INDUSTRY
Collaborators: name: Cortex
First posted: 2022-08-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected from the investigators' general patient population with a history of atrial fibrillation that meet eligibility criteria.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Acute Procedure Success
timeFrame: During the procedure
Secondary outcomes:
measure: Number of Participants With 12-month Freedom From AF Recurrence
timeFrame: 90 day - 12 months
Other outcomes:
Locations:
city: Athens
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid Holland
city: Warsaw
country: Poland
facility: Medicover Hospital
Study officials:
affiliation: Piedmont Athens Hospital
name: Kent Nilsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson KR, Anerao A, Kong MH, Derejko P, Szili-Torok T, Goyal S, Turagam M, Verma A, Castellano S. Electrographic Flow Mapping Provides Prognosis for AF Ablation Outcomes Across Two Independent Prospective Patient Cohorts. J Clin Med. 2025 Jan 22;14(3):693. doi: 10.3390/jcm14030693.
citation: Nilsson KR, Castellano S, Kong MH, Derejko P, Szili-Torok T, Goyal SK, Wijchers S, Turagam M, Reddy VY, Verma A; other members of the AF-FLOW Global Registry Study Group. AF-FLOW Global Registry Confirms Validity of Electrographic Flow Mapping as a Phenotyping Tool for Atrial Fibrillation. J Cardiovasc Electrophysiol. 2025 Mar;36(3):589-599. doi: 10.1111/jce.16568. Epub 2025 Jan 16.