Clnical Trials and Research
The Emory Heart & Vascular Center is dedicated to the development of new technology and therapy for heart rhythm disorders such as atrial fibrillation, atrial flutter, and arrhythmias. Emory’s experience and expertise in arrhythmia management allow us to lead and participate in national clinical trials and gives us the opportunity to access the newest advances in arrhythmia treatment technology.
Arrhythmia Clinical Trials at Emory University Hospital Midtown
Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy (LAPTOP-HF)
The purpose of this clinical study is to evaluate the safety and clinical effectiveness of use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, for use in patients with heart failure. The system allows patients to adjust their HF medications daily based on a physician-directed prescription plan and their current HF status, similar to the manner in which diabetes patients manage their insulin therapy. The goal of the LAPTOP-HF study is to demonstrate reductions in episodes of worsening heart failure (HF) and hospitalizations in patients who are managed with the left atrial pressure (LAP) management system (treatment group) versus those who receive only the current standard of care (control group).
Principal Investigator: David Delurgio, MD
Estimated Study Completion Date: August 2013
For more information or to enroll contact: Susan McCall, 404-686-1825, samccal@emory.edu; Paige Smith, 404-686-7992, pfsmith@emory.edu
Irrigated Ablation System Evaluation for AF (IRASE-AF)
The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.
Primary Outcome Measures:
• Freedom from symptomatic AF during nine months following the blanking period
• Confirmation of entrance block in the pulmonary veins
• Incidence of adverse events included in the pre-specified composite
Principal Investigator: David DeLurgio, MD
Estimated Study Completion Date: March 2013
For more information Contact: Susan McCall, 404-686-1825, samccal@emory.edu
Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL)
This is a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.
Primary Outcome Measures: Primary Efficacy Endpoint - The occurrence of stroke, cardiovascular death and systemic embolism.
Principal Investigators: David Delurgio, MD and Angel Leon, MD
Estimated Study Completion Date: November 2015
For more information or to enroll contact: Paige Smith, 404-686-7992, pfsmith@emory.edu
Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)
The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI) in patients at highest risk for adverse myocardial remodeling.
Primary Outcome Measures: Change in left ventricular end diastolic volume (LVEDV)
Principal Investigator: Angel Leon, MD
Estimated Study Completion Date: October 2014
To enroll contact: Susan McCall, 404-686-1825, Paige Smith, 404-686-7992
Arrhythmia Clinical Trials at Emory University Hospital
AIGISRx Envelope for Prevention of Infection Following Replacement With a Cardiac Resynchronization Therapy Device (CRT) (CENTURION)
The purpose of this study is to compare the incidence of cardiac rhythm management device (CRMD) infection and CRMD mechanical complication after CRMD replacement with a cardiac resynchronization therapy device (CRT) and AIGISRx Anti-Bacterial Envelope, to the incidence after replacement with a CRT and no AIGISRx.
Principal Investigator: Jonathan Langberg, MD
Estimated Study Completion Date: July 2012
Contact: Deanna Hil,l 404-727-4939, dmhill@emory.edu
AIGISRx Envelope for Prevention of Infection Following Replacement With an Implantable Cardioverter-Defibrillator (ICD) (CITADEL)
The purpose of this study is to compare the incidence of cardiac rhythm management device (CRMD) infection and CRMD mechanical complication after CRMD replacement with an Implantable Cardioverter-Defibrillator (ICD) and AIGISRx Anti-Bacterial Envelope, to the incidence after replacement with an ICD and no AIGISRx.
Principal Investigator: Jonathan Langberg, MD
Estimated Study Completion Date: July 2012
Contact: Deanna Hill, 404-727-4939, dmhill@emory.edu
For more information on specific studies, call Emory’s Electrophysiology Clinical Research Department:
• Emory University Hospital Midtown - 404-686-2504
• Emory University Hospital - 404-712-5592
To view a listing of clinical trials visit http://clinicaltrials.gov for a complete listing of all clinical trials in US and world.
