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FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation

NCT06260670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-10

Study results available
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Summary

FLOW EVAL-AF is a prospective, observational, single center pilot trial. The FLOW EVAL-AF trial is designed to identify driver sources in patients with persistent or longstanding persistent AF using EGF mapping and describe the activation patterns observed from concomitant high density mapping of those regions.

Conditions

  • Persistent Atrial Fibrillation
  • Longstanding Persistent Atrial Fibrillation
  • Atrial Fibrillation, Persistent
  • Arrhythmias, Cardiac

Interventions

DEVICE

Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter

Subjects will receive ElectroGraphic Flow™ (EGF) mapping with Ablamap® Software and a commercially available 64-pole basket mapping catheter (FIRMap™ Catheter, Abbott Laboratories, Abbott park, IL). The FIRMap™ catheter will be inserted into the right and left atrium to acquire 1 minute recordings of electrical signals in several standardized positions, and turn these into electrographic flow (EGF) maps. Subjects will receive concomitant high density (HD) electroanatomical mapping of these regions with the commercially available Ensite Precision mapping system and Advisor™ HD Grid mapping catheter (Abbott Laboratories, Abbott Park, IL).

Sponsors & Collaborators

  • Ablacon, Inc.

    lead INDUSTRY

Principal Investigators

  • Nishaki Mehta, MD · William Beaumont Hospitals, Royal Oak, MI

  • Philipp Sommer, MD · Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2022-10-28
Completion
2022-10-28
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06260670 on ClinicalTrials.gov