Crucial Areas on AF Termination | NCT02099643

Studies
Crucial Areas on AF Termination

NCT02099643

Sponsor

Hospital St. Joseph, Marseille, France

Status

Completed

Last Update Posted

Mar 31, 2014Estimated

Enrollment

113Actual

Phase

Not provided

Conditions

Atrial Fibrilation Termination Endpoint

Interventions

Not provided

Countries

France
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Mar 26, 2014

First Submission Date that Met QC Criteria

Mar 28, 2014

First Posted Date

Mar 31, 2014Estimated

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

Mar 28, 2014

Last Update Posted Date

Mar 31, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

SEITZ JULIEN, CARDIOLOGIST, Hospital St. Joseph, Marseille, FrancePrincipal Investigator

Lead Sponsor

Hospital St. Joseph, Marseille, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Recent data has demonstrated that focal sources are determinant in human atrial fibrillation (AF) perpetuation.

The investigators sought to identify crucial areas for AF perpetuation during our routine electrogram (EGM)-based substrate ablation.

Detailed Description

Not provided

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

5 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

113Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Atria fibrillation termination during procedure	conversion to atrial tachycardia (AT) or sinus rhythm	240 min

Secondary Outcomes

Measure	Description	Time Frame
Crucial points	Crucial points were defined by areas where ablation immediately extended the cycle length> 20% of AF CL, or regularized Atrial Fibrilation (AF) into Atrial Tachycardia (AT) or converted AF (or AT) into Sinus Rythm	240 min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Atrial Fibrilation
Undergoing EGM-based substrate ablation

Exclusion Criteria:

Age < 18

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

patients with symptomatic Atrial Fibrilation undergoing EGM-based substrate ablation were included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Saint Joseph		Marseille		13008	France
Hôpital Privé Jacques Cartier;

Type	Date	Date Unknown
Release	Apr 1, 2014
Reset	May 2, 2014
Release	Jun 18, 2015
Reset	Jul 17, 2015
Release	May 2, 2018
Reset	Nov 23, 2018

Submission Tracking

Estimated Results First Submitted Date

Apr 1, 2014

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 1, 2014			May 2, 2014
Jun 18, 2015