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CARMA

Current Studies

AAD: Randomization Controlled Trial of Antiarrhythmic Therapy following Pulmonary Vein Isolation for Atrial Fibrilation.

Objectives:The purpose of this study is to compare the differences in early recurrence of atrial fibrillation (ERAF) incidence and a 12-month incidence of atrial fibrillation (AF) recurrences for patients using antiarrhythmic drug (AAD) therapy during the first 8 weeks following pulmonary vein isolation (PVI) versus those patients who are not using AAD therapy during the first 8 weeks following PVI.  We hypothesize that those patients utilizing AAD therapy following PVI will have a lower incidence rate of ERAF and 12 month AF recurrences than those patients who are not on the AAD therapy following PVI.

Inclusion Criteria: 

  1. 18 years of age and older
  2. Scheduled to undergo pulmonary vein isolation at the University of Utah Hospital.

Exclusion Criteria:

  1. Patients who are unavailable/unwilling to continue follow-up via survey.
  2. Patients with active contraindications to any AAD therapy.


Location of the clinical trial: University of Utah Hospital
Status: Open for enrollment

For AAD Study information, please email research@carma.utah.edu

SOAR: Study Observing Anti-Arrhythmic Remodeling Using LGE_MRI

The primary objective of this soar  is to demonstrate how Multaq (dronedarone) may aid in the regression or slowing of progression of left atrial and ventricular fibrosis in patients with atrial fibrillation as assessed by LGE-MRI, using longitudinal data from a double-blinded, randomized prospective study of patients diagnosed with atrial fibrillation over a twelve month follow up period.

For SOAR Study information, please email research@carma.utah.edu

RADAR: Effect of Structural Remodeling on Scar Formation as Assessed by DE-MRI of the Left Atrium Following Open Irrigation Cooled-tip Radiofrequency Catheter Ablation of Atrial Fibrillation.

The primary objective of RADAR is to evaluate the impact of pre-ablation structural remodeling (fibrosis) on scar formation and progression in the LA as assessed by DE-MRI in patients who have undergone successful open irrigated cooled-tipped RF ablation of paroxysmal atrial fibrillation (PAF), using observational, longitudinal, retrospective data over a 12 month follow up period.

For RADAR Study information, please email research@carma.utah.edu

BSM: Body Surface Mapping

Objectives: To determine if high-resolution (32-lead) body surface electrocardiography is able to identify the presence of left atrial or ventricular scarring in patients being considered for radiofrequency catheter ablation.

Inclusion criteria:

  1. Age over 18years
  2. Referral for radiofrequency catheter ablation to treat atrial fibrillation or ventricular tachycardia.
  3. Deemed appropriate for this procedure by clinical cardiac Electrophysiologist.
  4. Presence of normal sinus rhythm at the time of enrollment

Exclusion criteria:

  1. Inability to give informed consent
Location of the clinical trial: University of Utah Hospital

Status: Open for enrollment.

For BSM Study information, please email research@carma.utah.edu

CASTLE-AF: Catheter Ablation Versus Standard Conventional Treatment in Patients with Left Ventricular Dysfunction and Atrial Fibrillation.

Objectives:  CASTLE-AF is a prospective, randomized, pilot study having as objective the evaluation of the effectiveness of radio frequency catheter-based atrial fibrillation (AF) ablation on mortality and morbidity compared to conventional treatment in subjects suffering from heart failure. About 40 patients with left ventricular dysfunction (ejection fraction ≤ 35%) and New York Heart Association class ≥ II, scheduled implantation of a dual chamber ICD or CRT-D with Home Monitoring capabilities, will be enrolled and randomized 1:1 to undergo either AF ablation or standard treatment as indicated in the ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation. In addition to planned and unplanned visits, the ablated patients will be constantly remotely monitored via Home Monitoring, in order to detect any recurrences of atrial fibrillation episodes, even if non symptomatic or short in duration, during an observational period of a minimum of 3 years per patient.   

Inclusion Criteria:

  1. Symptomatic paroxysmal, persistent or permanent AF
  2. Documented at least by one recording (ECG, Holter, Loop Recorder, ICD memory)
  3. Paroxysmal AF is defined as recurrent AF (>=2 episodes) that terminates spontaneously within seven days.
  4. Persistent AF is defined as AF that is sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion.
    1. Included within the category of  persistent AF is longstanding persistent AF, which is defined as continuous AF of greater than one year duration. The term permanent AF is defined as AF in which  cardioversion has either failed or not been attempted. 
  5. Failure or intolerance of ≥ 1 antiarrhythmic drug (mandatory for Amiodarone) 
  6. Left ventricular dysfunction with left ventricular ejection fraction ≤ 35% 
  7. NYHA class ≥ II 
  8. Indication for ICD therapy due to primary prevention or secondar 
  9. Dual chamber ICD or CRT with Home Monitoring capabilities (Lumax DR-T or successor) already implanted 
  10. Able to understand and willing to sign the Informed Consent Form 
  11. Age ≥18 years 
  12. Sufficient GSM-network coverage in the patient’s area

Exclusion Criteria:

  1. Documented left atrial diameter > 6 cm
  2. Contraindication for chronic anticoagulation therapy and Hepari
  3. Previous left heart ablation procedure, either by surgery or by percutaneous catheter, for atrial fibrillation
  4. Acute coronary syndrome, cardiac surgery, angioplasty or cerebrovascular accident within 2 months prior to enrollment
  5. Untreated hypothyroidism or hyperthyroidism
  6. Enrollment in another investigational drug or device study
  7. Indication for Cardiac Resynchronization Therapy
  8. Women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to usea reliable form of contraception
  9. Mental or physical inability to take part in the study
  10. Listed for a heart transplant
  11. Cardiac assist device implanted
  12. Planned cardiovascular intervention 
  13. Life expectancy ≤ 12 months
  14. Uncontrolled hypertension
  15. Requiring dialysis due to terminal renal failure
  16. Participation in another telemonitoring concept

Location of the clinical trial: University of Utah Hospital

Status: Open for enrollment

Status: Open for enrollment

For CASTLE-AF Study information, please  email research@carma.utah.edu

DECAAF: DE-MRI Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation

Objectives: This study seeks to expand the University of Utah experience with Delayed-Enhancement Magnetic Resonance Imaging (DE-MRI) image acquisition and processing in the management of atrial fibrillation (AF). The specific aims are as follows:

Aim 1: Successfully acquire DE-MRI scans of the left atrium in AF patients and quantify the extent of structural remodeling or fibrosis.

Aim 2: Successfully acquire DE-MRI scans of the left atrium 3 months post catheter ablation, quantify the extent of ablation related scarring and describe its distribution

Aim 3: Evaluate the relative contribution of clinical patient characteristics, pre-ablation fibrosis as well as post-ablation scarring in determining the long-term success of catheter ablation in maintaining normal rhythm.
Status: Open for enrollment

For detailed information regarding DECAAF Study Click here

For DECAAF Study information, please email research@carma.utah.edu

LA FIBROSIS: Characterization of Left Atrial Wall Tissue by Delayed Enhancement Magnetic Resonance Imaging: An AF Pilot Study.

Objectives: To characterize left atrial (LA) fibrosis in a normal population and in patients with atrial fibrillation (AF).  This data will be used to determine whether there is an identifiable MRI phenotype that predicts the development of atrial fibrillation. The 4 objectives for this study are:

  1. Characterize LA fibrosis in a healthy (non-atrial fibrillation) control population.
  2. Determine association of left atrial fibrosis with atrial fibrillation.
  3. Determine pattern of inheritance of LA fibrosis.
  4. Identify genes associated with left atrial fibrosis and atrial fibrillation.

Inclusion Criteria: 

  1. Subjects > 18 years old. (Females must be either post-menopausal >12 months, practicing a protocol-acceptable method of birth control [defined as injectable or implantable hormonal contraceptives, oral contraceptives, intrauterine device, diaphragm plus spermicide], or have had a hysterectomy, bilateral oophorectomy, or tubal ligation performed at least 6 months prior to enrollment).
  2. Able to read, understand, and sign the consent form.

Exclusion Criteria: 

  1. Control subjects must have no personal history or family history of atrial fibrillation.
  2. Any health related Gadolinium/MRI contraindications (e.g. allergy to Gd, pacemakers, defibrillators (ICD’s), other devices/implants contraindicated for MRI etc.).
  3. Patients weighing >300 lbs (MR image quality decreases due to increased BMI).
  4. History of prior cardiac or chest surgery (myocardial scarring/fibrosis from prior surgeries may confound data).
  5. Renal insufficiency (GFR < 30), severe kidney disorders/diseases (Gadolinium contraindication) Pregnant women 
  6. Individuals with cognitive impairments who are unable to give informed consent.

Participant Selection Criteria:

One hundred fifty control (non-AF) patients will be chosen from the University of Utah Cardiovascular Genetics Research database, which consists of >7,000 persons of all ages identified through randomly ascertained driver’s license records. 

For Objective 1: All patients who have presented to the University of Utah since June 2009 for pulmonary vein antrum isolation (PVAI) have undergone pre-ablation DE-MRI studies on a MAGNETOM Verio 3-T MRI scanner (Siemens Medical Solutions, Erlangen, Germany) in our EP-MRI suite.

For objective 2: Participants will consist of the last 100 patients who presented to the University of Utah EP-MRI lab for PVAI.

For objective 3: Family studies will be designed according to the results from the general population and case control analysis described above. The Cardiovascular Genetics Research Group has collected information on hundreds of families (several thousand family members) that have been used in genetic studies on hyperlipidemia and hypertension. Information has also been collected from relatives of persons in the patient control database. This will be used as a starting point in assembling families.

For objective 4: Not applicable. 

Location of the clinical trial: University of Utah Hospital
Status: Pre-Enrollment Phase

For LA Fibrosis Study information, please email research@carma.utah.edu