NCT04832646

Brief Summary

The purpose of this study is to retrospectively analyze electroanatomical data collected during persistent atrial fibrillation ablation procedures, combined with pre-ablation cardiac CT data, in order to:

  • define a new method for quantifying left atrial voltage in atrial fibrillation via a total energy map instead of a peak-to-peak amplitude map
  • confirm the association between epicardial fat localization and atrial conduction slowing

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 2, 2021

Last Update Submit

April 2, 2021

Conditions

Atrial Fibrillation, Persistent

Outcome Measures

Primary Outcomes (1)

  • correlation between voltage map in sinus rhythm and the new voltage map in atrial fibrillation using total energy calculation

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • correlation between atrial epicardial fat deposits and atrial conduction velocities slowing

    through study completion, an average of 1 year

Interventions

atrial fibrillation ablationPROCEDURE

persistent atrial fibrillation ablation with both AF and sinus rhythm map available

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted for a procedure in the interventional electrophysiology department of the CHRU de Nancy for AF ablation between March 2019 and March 2021, for whom electroanatomical and scannographic data are available

You may qualify if:

  • Persistant Atrial fibrillation ablation
  • Voltage map in sinus rhythm and in atrial fibrillation
  • Cardiac CT scan performed before ablation

You may not qualify if:

  • Incomplete data, poor quality ECG recordings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Charles GUENANCIA, MD, PhD

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Guenancia, MD, PhD

CONTACT

+33684693094charles.guenancia@chu-dijon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 6, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 6, 2021

Record last verified: 2021-04

Locations

FR(1)