Atrial FibrillationLAGO-FANCT02373982
Left Atrial Geometry and Outcomes After Atrial Fibrillation Ablation
An observational study of Atrial Fibrillation and Recurrence, run by Hospital Clinic of Barcelona at 9 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Recurrence
- How many people
- 417 participants
- Where
- 9 sitesSpain
- Study dates
- Jan 2013to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- > 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
Who cannot join
- Previous left atrial ablation or surgical procedure
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital de Sant Pau
Barcelona, Barcelona
Hospital del Mar
Barcelona, Barcelona
Hospital Clinic
Barcelona, 08036
Hospital Clinico San Carlos
Madrid
Hospital Puerta de Hierro
Madrid
Hospital Virgen de la Salud
Toledo
Hospital Clinico de Valencia
Valencia
Complexo Hospitalario de Vigo
Vigo
About this study
Official title: External Validation of the Left Atrial Sphericity as Predictor of Recurrence After Atrial Fibrillation Ablation: A Multicenter Observational Study.
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Recurrence
- Medical subject headings
- Atrial Fibrillation, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation Recurrence (>30 seconds)
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
- Investigators
- Felipe Bisbal, MD, Principal investigator, Germans Trias i Pujol HospitalLluís Mont, MD PhD, Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373982
- Sponsor's protocol ID
- LAGO-FA
- Acronym
- LAGO-FA
- Status last verified
- Apr 2017
- First submitted
- 23 Feb 2015
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23489827Bisbal 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.
PubMed 24390389Steinberg 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.
PubMed 23574013Bisbal 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.
PubMed 29659784
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the Left Atrial Sphericity as Predictor of Recurrence After Atrial Fibrillation Ablation: A Multicenter Observational Study.
- ClinicalTrials.gov ID
- NCT02373982
- Acronym / sponsor ID
- LAGO-FA / LAGO-FA
- Conditions
- Atrial Fibrillation, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- 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
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- > 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
Key exclusion criteria (1 listed)
- Previous left atrial ablation or surgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrial Fibrillation Recurrence (>30 seconds)
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Background: PubMed 23489827Bisbal 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.
- Background: PubMed 24390389Bisbal 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.
- Background: PubMed 23574013Steinberg 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.
- Derived from this study: PubMed 29659784Bisbal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Bisbal, MD principal investigator
Germans Trias i Pujol Hospital
Lluís Mont, MD PhD principal investigator
Hospital Clinic
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Recurrence, run by Hospital Clinic of Barcelona at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation Recurrence (>30 seconds) (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373982, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.