N/A
N=25
AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation
Atrial Fibrillation, Persistent · Atrial Fibrillation · Arrhythmias, Cardiac · Heart Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05481359 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Apr 2025
Primary outcome: Primary: Number of Participants With Acute Procedure Success — 13 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Electrographic Flow™ (EGF) mapping and ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ablacon, Inc.
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Procedure Success |
13 | — |
| SECONDARY Number of Participants With 12-month Freedom From AF Recurrence |
8; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Suitable candidate for intra-cardiac mapping and ablation of arrhythmias.
- Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
- Subjects with a history of documented symptomatic atrial fibrillation.
Exclusion Criteria
- Subjects who are not candidates for cardiac ablation procedures.
- Pregnant or nursing.
- 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.
Data sourced from ClinicalTrials.gov (NCT05481359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.