Artificial Intelligence Use for the Detection of Atrial F... | NCT03401931

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

another design of protocole is submitted for approuval before the start date

Expanded Access Info

Start Date

Jan 9, 2018Actual

Primary Completion Date

Jan 9, 2018Actual

Completion Date

Jan 9, 2018Actual

First Submitted Date

Jan 9, 2018

First Submission Date that Met QC Criteria

Jan 9, 2018

First Posted Date

Jan 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2020

Last Update Posted Date

Apr 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

SEITZ JULIEN, Cardiologist, Electrophysiology specialist, Hospital St. Joseph, Marseille, FrancePrincipal Investigator

Lead Sponsor

Hospital St. Joseph, Marseille, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

pilot clinical study, multicenter, prospective, open, nonrandomized

Detailed Description

The hypothesis is that ablation targeting PVI alone for the treatment of persistent AF is less efficient that ablation targeting electrophysiologic areas with spatio-temporal-dispersion with or without PVI

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AF termination	conversion to sinus rhythm or stable atrial tachycardia	during the ablation procedure

Secondary Outcomes

Measure	Description	Time Frame
AT termination	conversion to sinus rhythm	during the ablation procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: major patient with an indication of AF or AT ablation -

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

major patient with an indication of AF or AT ablation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julien SEITZ, MD	Hopital saint Joseph	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital d'Aix en Provence		Aix-en-Provence		13100	France
CHU Nice

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms