Evaluation of Predictive Factors for Recurrence of Persis... | NCT06620575

Studies
Evaluation of Predictive Factors for Recurrence of Persistent Atrial Fibrillation After Ablation

NCT06620575

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Completed

Last Update Posted

Oct 1, 2024Actual

Enrollment

542Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Atrial fibrillation ablation

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 2024

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

Mar 29, 2023Actual

Primary Completion Date

Apr 30, 2024Actual

Completion Date

Apr 30, 2024Actual

First Submitted Date

Sep 18, 2024

First Submission Date that Met QC Criteria

Sep 26, 2024

First Posted Date

Oct 1, 2024Actual

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

Sep 26, 2024

Last Update Posted Date

Oct 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single-center, retrospective, observational study based on data extracted from the medical records of patients who underwent a procedure for persistent atrial fibrillation 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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

542Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atrial fibrillation ablation	Procedure	Persistent atrial fibrillation ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence of persistent atrial fibrillation	The main objective of the study is to assess to what extent patient characteristics and conditions during the atrial fibrillation ablation procedure can identify predictive factors for recurrence. Recurrence (Yes/No) is the outcome variable to be explained.	Month 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient aged 18 years or older, who has been informed about the research
Patient who underwent a procedure for persistent atrial fibrillation ablation at Clairval Hospital since January 2014
Patient for whom data regarding the ablation procedure are available

Exclusion criteria:

Patient under legal protection, guardianship, or conservatorship
Patient who has expressed opposition to the use of their medical data (by completing and returning the opt-out form provided)

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

Patient who underwent a procedure for persistent atrial fibrillation ablation at Clairval Hospital since January 2014

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Privé Clairval		Marseille		13009	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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