Left Atrial Geometry and Outcomes After Atrial Fibrillation Ablation

NCT ID: NCT02373982

Last Updated: 2017-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

417 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-04-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Recurrence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Germans Trias i Pujol Hospital

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role collaborator

Hospital del Mar

OTHER

Sponsor Role collaborator

Hospital Virgen de la Salud

OTHER

Sponsor Role collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role collaborator

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role collaborator

Complejo Hospitalario Universitario de Vigo

OTHER

Sponsor Role collaborator

Puerta de Hierro University Hospital

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Josep Lluis Mont Girbau

MD, PhD, FESC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felipe Bisbal, MD

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Lluís Mont, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic

Locations

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Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital de Sant Pau

Barcelona, Barcelona, Spain

Site Status

Hospital del Mar

Barcelona, Barcelona, Spain

Site Status

Hospital Clinic

Barcelona, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Puerta de Hierro

Madrid, , Spain

Site Status

Hospital Virgen de la Salud

Toledo, , Spain

Site Status

Hospital Clinico de Valencia

Valencia, , Spain

Site Status

Complexo Hospitalario de Vigo

Vigo, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 23489827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24390389 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23574013 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29659784 (View on PubMed)

Other Identifiers

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LAGO-FA

Identifier Type: -

Identifier Source: org_study_id

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