Clinical Prognosis of Patients With Atrial Fibrillation D... | NCT03564327

Studies
Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation

NCT03564327

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Dec 22, 2025Actual

Enrollment

175Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

External electric cardioversion

Countries

France

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

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

Feb 14, 2019Actual

Primary Completion Date

Feb 9, 2023Actual

Completion Date

Sep 10, 2024Actual

First Submitted Date

Jun 11, 2018

First Submission Date that Met QC Criteria

Jun 11, 2018

First Posted Date

Jun 20, 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

Dec 16, 2025

Last Update Posted Date

Dec 22, 2025Actual

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

Identify the parameters of the predictive isochronous map for the clinical outcome of radiofrequency ablation in terms of absence of documented atrial fibrillation recurrence at 18 months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with atrial fibrillation	Experimental		Procedure: External electric cardioversion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
External electric cardioversion	Procedure	Three attempts (200-250 joules)	patients with atrial fibrillation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Atrial fibrillation relapse in non-reducible or non-inducible patients	Atrial fibrillation detected by routine or event-associated Holter examination	Month 18

Secondary Outcomes

Measure	Description	Time Frame
Atrial fibrillation relapse in non-reducible or non-inducible patients	Atrial fibrillation detected by routine or event-associated Holter examination	Month 12
Arrhythmia occurrence in non-reducible or non-inducible patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
The patient is at least 18 years old
The patient is available for 18 month follow-up
The patient has paroxysmal or persistent atrial fibrillation

Exclusion Criteria:

The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
The subject refuses to sign the consent
It is impossible to give the subject informed information
The patient is under safeguard of justice or state guardianship
The patient is pregnant or breastfeeding Early Study Exit Criteria: Patient does not have paroxysmal or persistent AF at the time of inclusion

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mathieu Granier, MD	CHU de Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Montpellier		Montpellier		34295	France
CHU Nimes

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided