NCT03401931

Brief Summary

pilot clinical study, multicenter, prospective, open, nonrandomized

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Geographic Reach
2 countries

3 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 9, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 9, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

Same day

First QC Date

January 9, 2018

Last Update Submit

April 24, 2020

Conditions

Fibrillation, AtrialTo Evaluate the Intraoperative Efficiency of the AIFIB Software in the Detection of Atrial Fibrillation Driver During an Ablation Procedure

Outcome Measures

Primary Outcomes (1)

  • AF termination

    conversion to sinus rhythm or stable atrial tachycardia

    during the ablation procedure

Secondary Outcomes (1)

  • AT termination

    during the ablation procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

major patient with an indication of AF or AT ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hopital d'Aix en Provence

Aix-en-Provence, 13100, France

Location

CHU Nice

Nice, 06000, France

Location

Isala Hospital

Zwolle, Netherland, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Julien SEITZ, MD

    Hopital saint Joseph

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist, Electrophysiology specialist

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 17, 2018

Study Start

January 9, 2018

Primary Completion

January 9, 2018

Study Completion

January 9, 2018

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations

FR(2)NL(1)