Clinical Trial Opportunities at the Atrial Fibrillation Center

Research plays a prominent role at the Atrial Fibrillation Center.  Current research interests include:

  • The use of ablation as initial therapy for atrial fibrillation
  • The combination of NAVx and intracardiac echocardiography for ablation of atrial fibrillation
  • Evaluation of pulmonary veins by intracardiac echocardiography and MRI
  • 3-dimensional CT imaging of the left atrium
  • Long-term results from intracardiac echocardiography-guided ablation
  • The effects of ablation on heart rate turbulence
  • Is conduction block across linear lesions necessary for clinical efficacy?
  • Clinical and echocardiographic predictors of success from ablation therapy
  • Evaluation of atrial fibrillation burden
  • Optimal anticoagulation management during atrial fibrillation ablation

Currently open clinical trials include:

"ENABLE" Endoscopic Ablation using Light Energy 

 
 Endoscopic Ablation

The purpose of this randomized study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System in the treatment of atrial fibrillation. This ablation system includes unique, custom devices that are used to apply laser energy under direct visualization to the pulmonary veins in participants presenting with recurrent, paroxysmal, symptomatic AF.

A few of the criteria that must be met include:

  • Male or female, 18-65 years of age
  • Failed or intolerant to one or two Class I or III antiarrhythmic drugs such as Sotalol, Flecainide, Dofetilide, or Amiodarone.
  • Have had at least three symptomatic AF episodes in the three months prior to enrollment with one documented episode in the past year prior to enrollment.
For more information, please visit the CardioFocus website.

FocusAF

“FocusAF”  Focused Circumferential UltraSound for the treatment of Atrial Fibrillation

The purpose of this study is to compare the effectiveness between an investigational catheter ablation method (a procedure used to destroy (ablate) areas of the heart that are causing abnormal rhythms) and normal medications used in the treatment of atrial fibrillation.   The HIFU Ablation System consists of a generator and catheter which work together to apply high intensity focused ultrasound (HIFU) energy to isolate the pulmonary veins of the heart. 

 

 

 

A few of the criteria that must be met include:

  • Male or female, 18-70 years of age
  • At least two symptomatic AF episodes within the past six months
  • Failed or intolerant to at least one FDA approved antiarrhythmic drug such as Flecainide, Sotalol, or Dofetilide.

For more information, please visit the ProRhythm website.



“ProtectAF”   WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation 

ProtectAF This is a randomized study comparing the WATCHMAN device to the standard warfarin (the blood-thinner known as Coumadin) therapy for people with atrial fibrillation.   The WATCHMAN device is designed to keep harmful sized blood clots that form in the left atrial appendage (LAA) from entering your blood stream, potentially causing a stroke. It is made of materials that are common to many medical devices. This device is designed to be permanently placed just behind or at the opening of the LAA.

 

A couple of the criteria that must be met include:

  • Male or female, 18 years of age or older
  • Eligible for long-term warfarin therapy, or able to come off warfarin therapy if LAA is sealed

View a video clip (mpeg) on the procedure. For more information, please visit the  Atritech website.


“Pace Term”  Pace Termination of AF From Mapping-Guided Sites
 

Pace Term
 
View a video clip of this procedure (windows media file | real player)
 

The purpose of this study is to collect data during an electrophysiology (EP) study (test that measures the electrical activity of your heart) to help identify the cause of atrial fibrillation. The research part of the study involves a new pacing (supplying electrical impulses to your heart) protocol to stop AF in patients.

A couple of the criteria that must be met include: 

  • Male or female, 18 years of age or older
  • Are scheduled to have an EP study and ablation procedure
If you are interested in any of these trials, or to find out if you are a candidate, please call Mary Jane Strickland at (434) 982-6401 or toll free (866) 607-AFIB(2342), or you may email Mary Jane.