Comprehensive Arrhythmia Research & Management (CARMA) Center
Our goal is to personalize atrial fibrillation treatment to fit the needs of every single patient. We do a Personalized AF management by treating the patient based on the degree of left atrial fibrosis (that is the amount of unhealthy tissue present in the left upper chamber of your heart). Our research has indicated that patients can be stratified into 4 stages based on the degree of left atrial structural remodeling (fibrosis): Utah I (<5% fibrosis), Utah II (5 – 20% fibrosis), Utah III (20 – 35% fibrosis) and Utah IV (> 35% fibrosis). We now know that patients with >35% fibrosis do not benefit favorably from a catheter ablation procedure. Utah stage III patients require a more extensive ablation as opposed to most patients belonging to Utah stages I and II. Learn more about CARMA.
Our Clinical Research Studies
DE-MRI determinant of successful radiofrequency catheter ablation of atrial fibrillation. This is a multi-center trial currently active at 16 centers spanning three continents (Europe, North America and Australia). In this trial, we are validating the DE-MR tool developed at the University of Utah at external sites as well as re-affirming that fibrosis can be used as a marker to identify suitable candidates for ablation and post-ablation scar is a good marker to predict recurrences in patients. All patients enrolled in the study undergo at least two DE-MRIs (one pre-ablation and another post-ablation); the EPs performing the catheter ablation procedure will be blinded to the results of the MRI. Enrollment for this trial has successfully ended (340 patients recruited in one year) and we are currently collecting additional data and analyzing the images acquired thus far.
Characterization of left atrial wall tissue by DE-MRI: an AF pilot study. In this study, we are characterizing the left atrial tissue structural remodeling in normal subjects (without any diagnosed AF or other structural heart diseases) and comparing it with the degree of left atrial structural remodeling seen in AF patients. This study has completed its first enrollment phase and we are currently analyzing results.
Study of anti-arrhythmic remodeling using DE-MRI. This is a randomized, placebo-controlled, double-blind study comparing the efficacy of Multaq (dronedarone) in reducing or slowing the progression of fibrosis in the left atrium of paroxysmal AF patients who have not undergone any left-sided ablation. Each enrolled patient receives a baseline MRI upon consent, will take Multaq/Placebo for one year, at the end of which he/she will receive another DE-MRI. The change in fibrosis between the 12-month and baseline MRI will be the primary outcome of the study. The study is being sponsored by Sanofi-Aventis. The enrollment for this study is now closed and is in the process of final data collection.
Catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation. This is a long-term observational study into which patients with both EF <35% and AF, and have an implanted with an ICD/CRT-D for primary or secondary prevention are recruited. Upon consent, patients are randomized to the ablation arm or the conventional treatment arm (pharmacotherapy) and followed (observed) for a period of 3 years. The end-point of the study is to compare the effectiveness of RF ablation to conventional therapy (drugs alone) in reducing morbidity and mortality in this cohort of patients. This study is currently actively recruiting patients.
Relationship between central nervous system activity and AF. This is a prospective study in which patients with AF coming in for a direct current cardioversion procedure (DCCV, shock your heart back to rhythm) will be requested to undergo a series of two functional MRI procedures, one prior to undergoing the DCCV and one post-DCCV. We will compare the autonomic nerve activity between the two FMRIs to identify the areas in the brain where activation was influenced by DCCV. This study was recently awarded a seed grant by the University of Utah and has been actively recruiting patients since February 2012.
Dabigatran (Pradaxa, a blood thinner) related effects on how atrial fibrosis develops in patients with atrial fibrillation. This is a prospective, observational study, which aims to identify if Dabigatran can reduce the amount of atrial fibrosis in the left atrium (left upper chamber of the heart) and subsequently reduce atrial fibrillation recurrences. This study is being sponsored by Boehringer-ingelheim and is actively recruiting patients.
This project approved by the IRB, allows us to collect blood from AF patients in order to reliably identify genes and other bio-markers that will help to better diagnose atrial fibrillation and also to characterize the inheritance pattern of AF (genes that make an individual get atrial fibrillation). This study is currently actively recruiting patients.
Genetic inheritance of atrial fibrillation and co-morbid conditions (such as heart failure, mitral valve disease, stroke, cardiomyopathy etc.). This project uses the genealogical records of Utah families, which will help discover genes for atrial fibrillation as well as to markers that will help us to treat patients differently based on how a patient would respond to certain drugs or to catheter ablation procedure. This study will also provide new insights into risk of developing several co-morbidities and the familial tendency to develop these conditions (such as congestive heart failure, mitral valve disease etc.) along with AF in patients.
Left atrial structural remodeling as an independent risk factor for stroke. We hope to answer the question of whether the degree of fibrosis or the progression of fibrosis would help to predict occurrence of stroke, specifically ischemic strokes. We are also hoping to identify incidences of silent strokes in AF patients.
The University of Utah Health Atrial fibrillation database is our most successful study – it includes collection of patients that have undergone DE-MRI and AF ablation at the University of Utah. This database has allowed us to conduct several retrospective studies and additionally enabled us to develop the Utah staging concept.
Apart from these clinical questions, we also conduct several AF screenings across the country, and have been able to identify incidences of undiagnosed arrhythmias (7.6%) in patients from 10 different states.
Our Basic Science Research
Our MRI physicists are striving to break new grounds everyday and make a real-time MRI-guided catheter ablation procedure a reality.
We have several electrophysiology studies and MRI studies looking at various characteristics to improve treatment of arrhythmias.
Atrial fibrillation (AF) is the most common arrhythmia affecting millions of Americans and costing billions of dollars in health care costs. Recent development in clinical cardiac electrophysiology have led to improved treatment options for patient with AF, success rates for drug therapy or interventional procedures are still far from optimal. With this project, we are developing animal models of AF in order to study the structural and electrophysiologic changes that lead to and accompany AF. We are using state of the art MRI imaging, clinical electrical mapping, histology, and other techniques to investigate the changes in cardiac tissue as AF develops in normal, healthy hearts and becomes permanent in diseased hearts. This revolutionary project will illuminate conditions that lead to AF, improve clinicians ability to select appropriate treatments for patients’ specific AF substrates, and aid in the development of improved AF treatment options for AF patients.