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Left Atrial Geometry and Outcomes After Atrial Fibrillation Ablation (LAGO-FA)

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ClinicalTrials.gov Identifier: NCT02373982
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : April 11, 2017
Sponsor:
Collaborators:
Germans Trias i Pujol Hospital
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital del Mar
Hospital Virgen de la Salud
Hospital San Carlos, Madrid
Fundación para la Investigación del Hospital Clínico de Valencia
Complejo Hospitalario Universitario de Vigo
Puerta de Hierro University Hospital
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona

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.


Condition or disease
Atrial Fibrillation Recurrence

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.

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Study Type : Observational
Actual Enrollment : 417 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: External Validation of the Left Atrial Sphericity as Predictor of Recurrence After Atrial Fibrillation Ablation: A Multicenter Observational Study.
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Atrial Fibrillation Recurrence (>30 seconds) [ Time Frame: One Year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373982


Locations
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Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Clinic
Barcelona, Spain, 08036
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, Spain
Sponsors and Collaborators
Hospital Clinic of Barcelona
Germans Trias i Pujol Hospital
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital del Mar
Hospital Virgen de la Salud
Hospital San Carlos, Madrid
Fundación para la Investigación del Hospital Clínico de Valencia
Complejo Hospitalario Universitario de Vigo
Puerta de Hierro University Hospital
Investigators
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Principal Investigator: Felipe Bisbal, MD Germans Trias i Pujol Hospital
Principal Investigator: Lluís Mont, MD PhD Hospital Clinic
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Josep Lluis Mont Girbau, MD, PhD, FESC, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02373982    
Other Study ID Numbers: LAGO-FA
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes