Left Atrial Geometry and Outcomes After Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

— LAGO-FA  

Official title:

External Validation of the Left Atrial Sphericity as Predictor of Recurrence After Atrial Fibrillation Ablation: A Multicenter Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373982
• Other study ID #: LAGO-FA
• Status: Completed
• Phase: N/A
• First received: February 23, 2015
• Last updated: April 10, 2017
• Start date: January 2013
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: April 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital Clinico de Valencia	Valencia
Spain	Complexo Hospitalario de Vigo	Vigo

Sponsors (9)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Complexo Hospitalario Universitario de Vigo, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Fundación para la Investigación del Hospital Clínico de Valencia, Germans Trias i Pujol Hospital, Hospital del Mar, Hospital San Carlos, Madrid, Hospital Virgen de la Salud, Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Bisbal F, Guiu E, Cabanas P, Calvo N, Berruezo A, Tolosana JM, Arbelo E, Vidal B, de Caralt TM, Sitges M, Brugada J, Mont L. Reversal of spherical remodelling of the left atrium after pulmonary vein isolation: incidence and predictors. Europace. 2014 Jun;16(6):840-7. doi: 10.1093/europace/eut385. Epub 2014 Jan 2. — View Citation

Bisbal F, Guiu E, Calvo N, Marin D, Berruezo A, Arbelo E, Ortiz-Pérez J, de Caralt TM, Tolosana JM, Borràs 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. — View Citation

Steinberg BA, Piccini JP. Left atrial remodeling: shape before size? J Cardiovasc Electrophysiol. 2013 Jul;24(7):760-1. doi: 10.1111/jce.12132. Epub 2013 Apr 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial Fibrillation Recurrence (>30 seconds)		One Year