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

Completed

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01150214

Run by

University of Utah

People needed

339

Starts

2010-07-01

Expected to finish

2012-09-01

Last updated by the study team

2017-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Florida Heart Rhythm Institute — Tampa, Florida, United States
• Loyola University Medical Center — Chicago, Illinois, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute (Centennial) — Nashville, Tennessee, United States
• Royal Adelaide Hospital — Norwood, South Australia, Australia
• Universitair Ziekenhuis Ghent — Ghent, Belgium
• Hôpital Cardiologique du Haut-Lévêque/Bordeaux — Bordeaux, France
• Kerckhoff Klinik — Bad Nauheim, Germany
• Coburg Klinik — Coburg, Germany
• Institut für Diagnostische und Interventionelle Radiologie - koln — Cologne, Germany
• Asklepios Klinik St. Georg — Hamburg, Germany
• Universitatsklinikum Leipzig — Leipzig, Germany
• St Antonius Ziekenhuis Hospital — Nieuwegein, Netherlands
• Hospital Clinic de Barcelona — Barcelona, Catalonia, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.