DECAAF: Delayed-Enhancement MRI (DE-MRI) Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation (DECAAF)
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|ClinicalTrials.gov Identifier: NCT01150214|
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : June 2, 2017
This is a multi-center, observational, 1-year prospective cohort study (1 year follow-up, at 3, 6 and 12 month) with approximately 675 participants. We will conduct a thorough outcomes assessment utilizing data from Magnetic Resonance Imaging (MRI) scans, as well as pre-procedure and follow-up data. Scans will be blinded to location of participating site. MRI scans will be sequenced and analyzed as they arrive from the database.
Imaging Protocol: All patients will undergo a Delayed-Enhancement MRI (DE-MRI) within 30 days prior to the atrial fibrillation (AF) ablation procedure. The purpose of the initial MRI is to quantify the degree of atrial structural remodeling or fibrosis pre-ablation. Following ablation, DE-MRI will be obtained at 3, 6, and 12 months follow-up to detect and quantify ablation-related scar formation.
Clinical Follow-up: The institution where the ablation was performed will continue post-procedural care following standard of care procedures.
Atrial arrhythmia recurrences will be catalogued up to one year post-ablation and predictors of recurrences of AF will be determined by statistical analysis. The specific mechanism and electrophysiological characteristics of atrial arrhythmia recurrence will also be analyzed.
Our hypotheses are (1) DE-MRI will reproducibly stage the progression left atrium fibrosis in AF; (2) DE-MRI will reproducibly aid in quantifying and identifying the distribution of catheter ablation-related scarring in the left atrium; and (3) the stage of left atrium fibrosis pre-ablation and the amount and location of scarring will predict success of catheter ablation therapy for AF.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Procedure: DE-MRI|
|Study Type :||Observational|
|Actual Enrollment :||339 participants|
|Official Title:||DECAAF: DE-MRI Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||September 2012|
All patients will undergo Delayed-Enhancement Magnetic Resonance Imaging (DE-MRI)to quantify the degree of atrial structural remodeling or fibrosis pre-ablation and DE-MRI will be obtained at 3, 6, and 12 months follow-up to detect and quantify ablation-related scar formation.
Using Delayed-Enhancement Magnetic Resonance Imaging (DE-MRI) to identify fibrotic and scarred cardiac tissue. DE-MRI is a non-invasive method of identifying the extent and the distribution of structural remodeling or fibrosis and scarring associated with atrial fibrillation both pre- and post-ablation.
- Relationship between extent of pre-ablation fibrosis and recurrence post-ablation [ Time Frame: 1 year ]The percentage of pre-ablation fibrosis in atrial fibrillation patients can significantly impact the incidence of recurrences post-ablation.
- Relationship between extent of Post-ablation scar and incidence of atrial fibrillation recurrences post-catheter ablation for AF [ Time Frame: Post-ablation scar ]The extent of lesions created by ablation may have an impact on the incidence of recurrence of AF post-ablation
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): NCT01150214
|United States, Florida|
|Florida Heart Rhythm Institute|
|Tampa, Florida, United States, 33606|
|United States, Illinois|
|Loyola University Medical Center|
|Chicago, Illinois, United States, 60153|
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|University of Pennsylvania Hospital|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Sarah Cannon Research Institute (Centennial)|
|Nashville, Tennessee, United States, 37203|
|Australia, South Australia|
|Royal Adelaide Hospital|
|Norwood, South Australia, Australia, 5067|
|Universitair Ziekenhuis Ghent|
|Ghent, Belgium, 9000|
|Hôpital Cardiologique du Haut-Lévêque/Bordeaux|
|Bordeaux, France, 33604|
|Bad Nauheim, Germany, 61231|
|Coburg, Germany, 96450|
|Institut für Diagnostische und Interventionelle Radiologie - koln|
|Asklepios Klinik St. Georg|
|Hamburg, Germany, 20099|
|Leipzig, Germany, 04103|
|St Antonius Ziekenhuis Hospital|
|Nieuwegein, Netherlands, 3430|
|Hospital Clinic de Barcelona|
|Barcelona, Catalonia, Spain, 08036|
|Principal Investigator:||Nassir F Marrouce, MD, FHRS||CARMA Center, University of Utah|