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

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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
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