DECAAF: Delayed-Enhancement MRI (DE-MRI) Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation
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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 |
- 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.
- 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
| Estimated Enrollment: | 675 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | June 2012 |
| 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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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and 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 | |
| Principal Investigator: | Nassir F Marrouce, MD, FHRS | CARMA Center, University of Utah |
More Information
Additional Information:
Publications:
| 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: | February 15, 2012 |
| 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 May 16, 2013