NCT02373982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

February 23, 2015

Last Update Submit

April 10, 2017

Conditions

Atrial FibrillationRecurrence

Outcome Measures

Primary Outcomes (1)

  • Atrial Fibrillation Recurrence (>30 seconds)

    One Year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • \> 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

You may not qualify if:

  • Previous left atrial ablation or surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de Sant Pau

Barcelona, Barcelona, Spain

Location

Hospital del Mar

Barcelona, Barcelona, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

Hospital Virgen de la Salud

Toledo, Spain

Location

Hospital Clinico de Valencia

Valencia, Spain

Location

Complexo Hospitalario de Vigo

Vigo, Spain

Location

Related Publications (4)

  • 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.

    PMID: 23489827BACKGROUND

  • 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.

    PMID: 24390389BACKGROUND

  • 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.

    PMID: 23574013BACKGROUND

  • 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.

    PMID: 29659784DERIVED

MeSH Terms

Conditions

Atrial FibrillationRecurrence

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Felipe Bisbal, MD

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

  • Lluís Mont, MD PhD

    Hospital Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FESC

Study Record Dates

First Submitted

February 23, 2015

First Posted

February 27, 2015

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

April 1, 2017

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

ES(9)