PELEX-C: A high-resolution, wireless ECG system for infants/children

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$166,722.00
Award Year:
2008
Program:
STTR
Phase:
Phase I
Contract:
1R41HL093953-01
Award Id:
89548
Agency Tracking Number:
HL093953
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
PINMED, INC., 245 MELWOOD AVE, #501, PITTSBURGH, PA, 15213
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
142197909
Principal Investigator:
() -
Business Contact:
() -
vs@pinmed.net
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): We propose to adapt a high-resolution ECG system (PELEX) that includes the features of programmable ltV resolution ECG data acquisition, wireless communication, near real-time advanced analysis algorithms, and provider notification to identify age- and gender-specific ECG patterns in normal infants and in infants with congenital heart disease (CHD) before and after cardiac surgery (PELEX-C). Abnormal cardiac electrical activity in infants and children is associated with cardiac failure following heart surgery and is an important cause of prolonged hospitalization and sudden death. (1-28) Despite a successful operation, the risk for cardiac decompensation and death in infants with CHD persists following hospital discharg e and has been associated with post-operative arrhythmias. The risk for sudden death can be as high as 16% for infants with Hypoplastic Left Heart Syndrome following the palliative Norwood procedure. Recent studies have applied high-resolution (ltV) electr ocardiogram (ECG) analysis techniques to detect myocardial ischemia and injury in children with CHD.(19,24-28) In addition to the usual ECG parameters of heart rate (HR), cardiac time intervals (PR, QRS, QTC,), and changes in the position of ST segments, high- resolution ECG analysis can detect a broad range of clinically relevant ltV variations in cardiac waveforms that represent increased risk for arrhythmia and death in adults but comparable studies have not been done in children. Thus, there is a clin ical need to rapidly detect abnormal ECG patterns in pediatric patients and an opportunity to use the features of a PELEX system to identify subtle, sub-threshold pro-arrhythmic ECG patterns associated with cardiac injury/ischemia.(29-37)Medical interventi on can then optimize patient outcomes by treating patients at risk for developing life-threatening arrhythmias prior to clinical decompensation. SPECIFIC AIM 1. Adapt the PELEX acquisition and analysis algorithms (e.g. normative values of heart rate, QRS a nd T wave axis, depolarization, repolarization, temporal instability, arrhythmia) to the age and gender-specific parameters and patterns of infants and children (PELEX-C). SPECIFIC AIM 2. Use PELEX-C to acquire and analyze cardiac electrical patterns in a prospective, cross-sectional cohort of healthy infants (n = 40). SPECIFIC AIM 3. Use PELEX-C to acquire and analyze normal and abnormal cardiac electrical activity in a prospective, cross-sectional cohort of infants with congenital heart disease undergoing cardiac surgery including cardiopulmonary bypass in the first 90 days of life (n = 20). The PELEX-C system represents an age-specific extension of the FDA-cleared, high-resolution, wireless, personal ECG system (PELEX) to a unique sub-population of at-ris k infants and children. A much larger market is anticipated for monitoring changes in cardiac electrical activity in children with non-cardiac diseases such as chronic lung diseases, cancer, and neurologic disorders.(38, 38b-e). PUBLIC HEALTH RELEVANCE : We propose to identify unique patterns of abnormal cardiac electrical activity after congenital heart surgery using high-resolution recording and multi-dimensional analysis so that we can identify post- operative patients at risk for cardiac arrhythmia a nd clinical deterioration. Medical care can then be intensified for these high-risk infants in order to prevent post-operative arrhythmias, prolonged hospitalization, higher morbidity and hospital costs, and sudden death. Identifying at-risk patterns of cardiac electrical activity using high-resolution analysis (of patterns now considered normal using standard analysis) may also be very important in identifying patients with non-cardiac diseases who are at increased risk for arrhythmia due to treatment wi th drugs that directly or indirectly impact cardiac electrical and mechanical performance.

* information listed above is at the time of submission.

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