Study:
DECAAF: DE-MRI Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation
Rationale:
n/a
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.
Study Status: Enrolling by invitation
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Atrial Fibrillation |
Procedure: DE-MRI |
N/A |
Verified by
University of Utah
June, 2010
Sponsored by: University of Utah
Information provided by: University of Utah
ClinicalTrials.gov identifier: NCT01150214
Study Type: Interventional
Study Design: Observational Model: Cohort, Time Perspective: Retrospective
Cleveland Clinic
Cleveland, Ohio 44195
United States
Nassir F Marrouce, MD, FHRS., Principal Investigator