Clinical trial NCT02373982: Left Atrial Geometry and Outcomes After Atrial Fibrillation Ablation
Official title: External Validation of the Left Atrial Sphericity as Predictor of Recurrence After Atrial Fibrillation Ablation: A Multicenter Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Recurrence
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Germans Trias i Pujol Hospital
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Hospital del Mar
name: Hospital Virgen de la Salud
name: Hospital San Carlos, Madrid
name: Fundación para la Investigación del Hospital Clínico de Valencia
name: Complejo Hospitalario Universitario de Vigo
name: Puerta de Hierro University Hospital
First posted: 2015-02-27
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

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.

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

Primary outcomes:
measure: Atrial Fibrillation Recurrence (>30 seconds)
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
city: Vigo
country: Spain
facility: Complexo Hospitalario de Vigo
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Felipe Bisbal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic
name: Lluís Mont, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. No abstract available.
citation: Bisbal F, Alarcon F, Ferrero-de-Loma-Osorio A, Gonzalez-Ferrer JJ, Alonso C, Pachon M, Tizon H, Cabanas-Grandio P, Sanchez M, Benito E, Teis A, Ruiz-Granell R, Perez-Villacastin J, Vinolas X, Arias MA, Valles E, Garcia-Campo E, Fernandez-Lozano I, Villuendas R, Mont L. Left atrial geometry and outcome of atrial fibrillation ablation: results from the multicentre LAGO-AF study. Eur Heart J Cardiovasc Imaging. 2018 Sep 1;19(9):1002-1009. doi: 10.1093/ehjci/jey060.