Left Atrial Geometry and Outcomes After Atrial Fibrillati... | NCT02373982

Studies
Left Atrial Geometry and Outcomes After Atrial Fibrillation Ablation

NCT02373982

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Apr 11, 2017Actual

Enrollment

417Actual

Phase

Not provided

Conditions

Atrial Fibrillation
Recurrence

Interventions

Not provided

Countries

Spain

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

Apr 2017

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

Jan 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Apr 2017Actual

First Submitted Date

Feb 23, 2015

First Submission Date that Met QC Criteria

Feb 26, 2015

First Posted Date

Feb 27, 2015Estimated

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 10, 2017

Last Update Posted Date

Apr 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Josep Lluis Mont Girbau, MD, PhD, FESC, Hospital Clinic of BarcelonaPrincipal Investigator

Lead Sponsor

Hospital Clinic of BarcelonaOTHER

Collaborators

Name	Class
Germans Trias i Pujol Hospital	OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	OTHER
Hospital del Mar	OTHER
Hospital Virgen de la Salud

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

This is a Multicenter Observational 1-year retrospective cohort study evaluating the predictive value of the Left Atrial Sphericity on the recurrence rate of atrial fibrillation after pulmonary vein ablation procedure.

Inclusion of consecutive patients undergoing AF ablation during 2013 in whom a 3D-imaging of the left atrium (Cardiac CT or MRA) was acquired prior to the procedure and when procedural/follow-up data was prospectively collected.

Detailed Description

Validation of the predictive value of the Left Atrial Sphericity for AF recurrence of atrial fibrillation after a pulmonary vein ablation procedure in an external, multicenter cohort.

In total, 9 centers will include consecutive patients who underwent AF ablation from january to december 2013 in whom a 3D-imaging of the left atrium (Cardiac CT or MRA) was acquired prior to the procedure and when procedural/follow-up data was prospectively collected.

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

417Actual

Measure	Description	Time Frame
Atrial Fibrillation Recurrence (>30 seconds)		One Year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years old
First AF ablation procedure
Prior 3D-imaging of the left atrium (CT or MRA)
Prospective collection procedural and outcome data
Obtention of Informed Consent

Exclusion Criteria:

Previous left atrial ablation or surgical procedure

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

Multi-center cohort of consecutive patients undergoing first ablation of symptomatic drug-refractory AF during 2013 in whom 3D-imaging of the left atrium was performed (Cardiac CT or MRA).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felipe Bisbal, MD	Germans Trias i Pujol Hospital	Principal Investigator
Lluís Mont, MD PhD	Hospital Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari Germans Trias i Pujol		Badalona	Barcelona	08916	Spain
Hospital de Sant Pau

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23489827	Background	Bisbal F, Guiu E, Calvo N, Marin D, Berruezo A, Arbelo E, Ortiz-Perez J, de Caralt TM, Tolosana JM, Borras R, Sitges M, Brugada J, Mont L. Left atrial sphericity: a new method to assess atrial remodeling. Impact on the outcome of atrial fibrillation ablation. J Cardiovasc Electrophysiol. 2013 Jul;24(7):752-9. doi: 10.1111/jce.12116. Epub 2013 Mar 14.
24390389

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