Arrhythmia Research Technology‘s (NYSE:HRT) Signal-Averaged Electrocardiography device is 1 of only 2 ECG tests that can predict ventricular arrhythmias in patients with prior heart attacks, data from an NIH-funded multi-center clinical trial proves.
The 22-center trial evaluated 484 patients considered at high risk of ventricular arrhythmias because of low ejection fraction, using more than 10 different ECG-based diagnostic methodologies and algorithms, including 12-lead ECG, 24-hour Holter monitoring, T wave alternans and SAECG-derived parameters, according to a press release from the Fitchburg, Mass.-based company.
Patients received implantable cardiac defibrillators (ICD) as primary prevention against sudden cardiac death. Data from the trial were released last week at the annual Heart Rhythm Society meeting.
"Our multi-center study rigorously applied a large battery of clinically available ECG test methods," Dr. Wojciech Zareba, Professor of Medicine, Director of the Heart Research Follow Up Program at the University of Rochester and Principal Investigator of this NIH-funded study said in a press statement. "Out of these we found only two ECG-based test results capable of predicting ventricular arrhythmia risk: total root-mean-square voltage of less than 25 microvolts from the SAECG, and greater than 500 ventricular premature beats from 24-hour Holter recordings.
"We are pleased that these results demonstrate an important role of SAECG in the assessment of risk for ventricular tachycardia or fibrillation in post-myocardial infarction patients," Zareba continued. "These findings may pave the way for more targeted implantation of ICD’s in heart attack patients that are most likely to develop potentially lethal ventricular arrhythmias, and hence benefit from ICD implant."
Among the major cardiac centers participating in the study were University of Rochester, Duke University, University of Pennsylvania and UMass Memorial Hospital.
Each year approximately 1.5 million Americans suffer a myocardial infarction (MI); these heart attack survivors are susceptible to sudden cardiac death, which claims an estimated 325,000 lives annually, according to Arrhythmia Research Technology.
"We are pleased that our patented SAECG technology made such an important contribution to this study," president and CEO Salvatore Emma Jr. said in a press statement. "The ability for the Company’s PREDICTOR SAECG analysis software to provide better patient selection for ICD implantation is extremely encouraging."