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DECAAF: Delayed-Enhancement MRI (DE-MRI) Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation (DECAAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01150214
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : June 2, 2017
Information provided by (Responsible Party):
Nassir F. Marrouche, MD, University of Utah

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 339 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.
Procedure: DE-MRI
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

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
The study population will consist of those patients who have undergone catheter ablation for atrial fibrillation.

Inclusion Criteria:

  • Patients who underwent an AF ablation as per recent Heart Rhythm Society (HRS) consensus document, as per the University of Utah AFIB Database (IRB_00020347)
  • Patients who have had an MRI post-ablation.
  • Age ≥18 years.

Exclusion Criteria:

  • Contraindication for DE-MRI with a full dose of Gadolinium-based contrast agent.
  • Previous left atrial ablation or surgical procedure
  • Renal failure with CrCl <60 ml/min
  • Women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception
  • Mental or physical inability to take part in the study
  • Uncontrolled hypertension
  • Morbid obesity (BMI > 35), or inability to be placed in MRI due to body mass.
  • Patients who have not had a DE-MRI post-ablation.

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 identifier (NCT number): NCT01150214

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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
Kerckhoff Klinik
Bad Nauheim, Germany, 61231
Coburg Klinik
Coburg, Germany, 96450
Institut für Diagnostische und Interventionelle Radiologie - koln
Cologne, Germany
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Universitatsklinikum Leipzig
Leipzig, Germany, 04103
St Antonius Ziekenhuis Hospital
Nieuwegein, Netherlands, 3430
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
University of Utah
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Principal Investigator: Nassir F Marrouce, MD, FHRS CARMA Center, University of Utah
Calkins H, Brugada J, Packer DL, Cappato R, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, Haines DE, Haissaguerre M, Iesaka Y, Jackman W, Jais P, Kottkamp H, Kuck KH, Lindsay BD, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Natale A, Pappone C, Prystowsky E, Raviele A, Ruskin JN, Shemin RJ; Heart Rhythm Society; European Heart Rhythm Association; European Cardiac Arrhythmia Society; American College of Cardiology; American Heart Association; Society of Thoracic Surgeons. HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation developed in partnership with the European Heart Rhythm Association (EHRA) and the European Cardiac Arrhythmia Society (ECAS); in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Endorsed and approved by the governing bodies of the American College of Cardiology, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, and the Heart Rhythm Society. Europace. 2007 Jun;9(6):335-79. Erratum in: Europace. 2009 Jan;11(1):132.

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Responsible Party: Nassir F. Marrouche, MD, Associate Professor, University of Utah Identifier: NCT01150214    
Other Study ID Numbers: IRB_00039522
First Posted: June 24, 2010    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: June 2017
Keywords provided by Nassir F. Marrouche, MD, University of Utah:
atrial fibrillation
magnetic resonance imaging
left atrium
structural remodeling
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes