Last updated on July 2013

ALERTS (Angel Med): Implanted device designed to continuously monitor the electrocardiogram signals and detect shifts that could indicate of a blockage of a coronary artery


Brief description of study

ALERTS (Angel Med): Implanted device designed to continuously monitor the electrocardiogram signals and detect shifts that could indicate of a blockage of a coronary artery

Detailed Study Description

The implant device is designed to continuously monitor the electrocardiogram signal and detect ST shifts that could be indicative of a blockage of a coronary artery. If it detects such events, the Guardian System then alerts the patient to seek immediate medical attention by delivering vibratory, auditory and visual alerts.

Patient Inclusion Criteria: Adults sufficiently ill to warrant an isolated AVR with or without concomitant procedures such as CABG or another valve reconstruction. (The three remaing valves must be of native tissue). Likely survival - 1 year post-op)

Patient Exclusion Criteria:
Candidates will be excluded from the study if ANY of the following conditions apply: In the investigator’s opinion, subject lacks ability to respond appropriately to alarms, e.g., illiteracy, poor memory or cognitive function, dementia or other condition affecting memory function, etc.

There is known compromised tissue at the site of lead implantation in the apex of the right ventricle, e.g., prior infarct affecting the RV apex location.

A permanent pacemaker or ICD is already in place or the patient is indicated for ICD or pacemaker implantation based on the guidelines published by the American College of Cardiology as Class I and IIa recommendations. Class IIb recommendations are at the investigator’s discretion.

Subject cannot feel the IMD vibration when placed on top of the skin on the left pectoral side of the chest.
AND OTHERS

Clinical Study Identifier: TX1576

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Veta Markland-Gentles, RN

Holy Cross Jim Moran Heart and Vascular Research Institute
Fort Lauderdale, FL USA
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