Local Cardiologist Presents Findings of Clinical Trial
Lafayette Cardiologist William M. Bailey, M.D., who helped conduct a clinical trial on an implantable MRI-compatible defibrillator, presented his findings at an American College of Cardiology conference in San Diego, CA, on March 14. This study was the first one approved by the Federal Drug Administration for investigational use of an implantable cardioverter-defibrillator (ICD) in a Magnetic Resonance Imaging (MRI) environment.
Dr. Bailey, who practices at Louisiana Heart Rhythm Specialists, conducted his research at Lafayette General Medical Center, the first hospital in Louisiana to test the device. Nationwide, the study involved over 30 study sites and 200 patients.
The study’s conclusion affirmed that the BIOTRONIK ProMRI® pacemaker system demonstrated clinical safety and effectiveness in patients subjected to head and lower lumbar MRI conditions. Permanent cardiac pacemakers have historically been withheld from MRI, a disadvantage of having an ICD.
Each year, thousands of patients receive ICD’s, which protect them from fatal heart rhythms. Before this study, these patients were not permitted to receive an MRI scan due to the risk the scanner may interfere with the function of the ICD. An estimated 50 to 75 percent of patients with ICD’s will need an MRI during their lifetime.
“This implant marks an important first step in better addressing the critical need for improved imaging capabilities for heart rhythm patients,” says Dr. Bailey. “This trial has provided much needed information toward expanding diagnostic capabilities for patients,” he says.
LGMC was one of the first centers in the country used to evaluate the Iforia system with Setrox and Linoxsmart leads during an MRI scan. All ICD systems used in the study are commercially available, but await FDA approval specifically for use in the MRI environment. Dr. Bailey presented his findings along with a group of physicians from prestigious research institutions from across America and outside the United States.
This was the final phase of the trial, sponsored by BIOTRONIK, Inc., which now awaits Federal Drug Administration approval.
For more information on other clinical trials available at Lafayette General Medical Center, call (337) 289-8658 or visit LafayetteGeneral.com/ClinicalTrials.