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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nassir F. Marrouche, MD, University of Utah
ClinicalTrials.gov Identifier:
NCT01150214
First received: June 22, 2010
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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 Intervention
Atrial Fibrillation
Procedure: DE-MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DECAAF: DE-MRI Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Relationship between extent of pre-ablation fibrosis and recurrence post-ablation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The percentage of pre-ablation fibrosis in atrial fibrillation patients can significantly impact the incidence of recurrences post-ablation.


Secondary Outcome Measures:
  • Relationship between extent of Post-ablation scar and incidence of atrial fibrillation recurrences post-catheter ablation for AF [ Time Frame: Post-ablation scar ] [ Designated as safety issue: No ]
    The extent of lesions created by ablation may have an impact on the incidence of recurrence of AF post-ablation


Enrollment: 339
Study Start Date: July 2010
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
DE-MRI
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.

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Detailed Description:

Atrial fibrillation (AF) is an electrophysiological condition characterized by a disorganized electrical activity in the atria of the heart. AF is associated with structural heart disease including hypertension, systolic and diastolic ventricular dysfunction and valvular heart disease. It represents a significant public health problem with the increasing longevity of the general population. A major determinant of the progression of AF is structural remodeling or fibrosis that occurs in the left atrium. A more extensively remodeled atrium represents the substrate needed for the arrhythmia to persist. Structural remodeling is also a major determinant for success of rhythm control strategies in AF. While catheter ablation has been reproducibly shown to be superior to anti-arrhythmic drug therapy for rhythm control in AF, the success of this procedure is significantly affected by the extent of structural remodeling present at the time of catheter ablation.

Delayed-Enhancement Magnetic Resonance Imaging (DE-MRI) has been demonstrated to be a very effective modality in identifying fibrotic and scarred cardiac tissue with excellent correlation with autopsy findings. This is related to the characteristics of Gadolinium, an extracellular contrast agent that is very effective in identifying regions of fibrotic non-viable myocardium. DE-MRI technology can be a very powerful, non-invasive method, of identifying the extent and the distribution of structural remodeling or fibrosis associated with AF.

Applying DE-MRI technology to the atrium causes significant technical challenges. The atrial wall is often a few millimeters thick which requires high spatial resolution to obtain adequate and useful images. In addition, image acquisition has to be gated to the diastolic phase of the atrial contraction cycle, which may be difficult to do when the patient is in AF. The ongoing research at the University of Utah has shown significant progress and very promising results overcoming the challenges mentioned. Specific image acquisition sequences have allowed for reproducible identification of high pixel intensity regions within the 2-dimensional images of the atrial wall. Three-dimensional reconstruction of the entire left atrium then provides a quantification of the overall volume occupied by these hyper-enhanced regions relative to the entire left atrial wall volume. Used prior to catheter ablation, DE-MRI can therefore identify regions of significant structural remodeling or fibrosis. The same technology has also been shown to be very useful in examining the amount and distribution of ablation related scarring.

Clinical patient characteristics will be collected for this study from clinic visits and chart reviews.

Imaging Protocol: All patients will undergo a DE-MRI within 30 days prior to the AF ablation procedure using a DE-MRI protocol. 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 (Figs. 4-5).

Clinical Follow-up: The institution where the ablation was performed will continue post-procedural care following standard of care procedures. Monitoring and definition of atrial arrhythmia AF recurrences will be guided by the HRS consensus document on ablation of atrial fibrillation.

Clinical and MRI data will be stored using the IRB-approved University of Utah database. De-identified clinical data and MRI images from participating institutions will also be submitted to the database, and will be processed at the University of Utah for pre- and post-ablation fibrosis and scar quantification. The ablation strategy utilized and procedural endpoint will be left to the discretion of the operators at the participating sites. This data will also be collected and included in the final analysis. MRI image processors at the University of Utah will be blinded to the ablation technique and mother institution using a unique de-identified study participant ID number.

Atrial arrhythmia recurrences will be catalogued up to one year post-ablation and predictors of recurrences determined by multivariate/survival analysis. The specific mechanism and electrophysiological characteristics of atrial arrhythmia recurrence will also be analyzed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150214

Locations
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, Utah
CARMA Center, University of Utah
Salt Lake City, Utah, United States, 84132
Australia, South Australia
Royal Adelaide Hospital
Norwood, South Australia, Australia, 5067
Belgium
Universitair Ziekenhuis Ghent
Ghent, Belgium, 9000
France
Hôpital Cardiologique du Haut-Lévêque/Bordeaux
Bordeaux, France, 33604
Germany
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
Netherlands
St Antonius Ziekenhuis Hospital
Nieuwegein, Netherlands, 3430
Spain
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Nassir F Marrouce, MD, FHRS CARMA Center, University of Utah
  More Information

Additional Information:
Publications:
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. No abstract available. Erratum in: Europace. 2009 Jan;11(1):132.

Responsible Party: Nassir F. Marrouche, MD, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01150214     History of Changes
Other Study ID Numbers: IRB_00039522
Study First Received: June 22, 2010
Last Updated: September 17, 2013
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission
Australia: Human Research Ethics Committee
Spain: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
France: Institutional Ethical Committee
Belgium: Ethics Committee

Keywords provided by University of Utah:
atrial fibrillation
af
magnetic resonance imaging
mri
left atrium
fibrosis
structural remodeling

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014