Echocardiographic Markers of Atrial Fibrillation Recurren... | NCT05690529

Studies
Echocardiographic Markers of Atrial Fibrillation Recurrence Post Radiofrequency Ablation

NCT05690529

Sponsor

Unidade Local de Saúde de Coimbra, EPE

Status

Unknown status

Last Update Posted

Jan 19, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Ablation

Countries

Portugal

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

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2022Actual

Primary Completion Date

May 31, 2024Estimated

Completion Date

May 31, 2024Estimated

First Submitted Date

Jan 10, 2023

First Submission Date that Met QC Criteria

Jan 10, 2023

First Posted Date

Jan 19, 2023Actual

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

Jan 10, 2023

Last Update Posted Date

Jan 19, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Diogo de Almeida Fernandes, Dr., Unidade Local de Saúde de Coimbra, EPEPrincipal Investigator

Lead Sponsor

Unidade Local de Saúde de Coimbra, EPEOTHER

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

Determine echocardiographic predictors of atrial fibrillation recurrence post radiofrequency Ablation and evaluate markers of low voltage areas on 3D mapping.

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

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No recurrence		No recurrence of AF	Procedure: Ablation
Recurrence		Recurrence of AF	Procedure: Ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ablation	Procedure	Radiofrequency AF ablatoon	No recurrence Recurrence

Measure	Description	Time Frame
Recurrence		1 year

Measure	Description	Time Frame
Low voltage areas		At procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

paroxysmal or persistent ablation

Exclusion Criteria:

previous AF ablation
previous left atrial ablation
refusal to give informed consent
congenital cradiomiopathy

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 undergoing radiofrequency AF ablation guided by 3D mapping

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diogo Fernandes	Contact	239400400		11750@chuc.min-saude.pt

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Hospitalar e Universitário de Coimbra	Recruiting	Coimbra			Portugal

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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