ANALYZE-ST - st monitoring to detect acs events in icd patients study (Analyze ST)

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

ANALYZE-ST - st monitoring to detect acs events in icd patients study (Analyze ST)

Description

Studies have shown that patients who have large areas of cardiac muscle damage also have a clear correlation in the ST shifts in their ECGs. St. Jude Medical has developed a device that will perform continuous monitoring of the ST segment. This device is attached to the right ventricular tip of a standard pacemaker or implantable cardiac device at the time of insertion. The any change in the ST segment is detected, it will send an alarm to the patient to notify their physician.

Details
Condition Pacemaker (ICD)
Clinical Study IdentifierTX137621
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have an indication for an ICD implantation or pulse generator change 2. Have documented coronary artery disease. Documented coronary artery disease is defined as having at least one of the following present
a) evidence of a prior MI on ECG and/or cardiac enzymes, b) prior revascularization (by coronary artery bypass grafting or percutaneous coronary intervention) c) angina and/or ST-T wave abnormalities indicative of ischemia on exercise stress test, nuclear stress test, or echo stress test, or d) coronary artery disease diagnosed by coronary angiography
Willing and able to comply with protocol requirements, including keeping all required visits
Willing to participate in the study and able to sign an IRB approved informed consent form
Willing to and capable of using Merlin@home
Be at least 18 years of age when enrolled in the study

Exclusion Criteria

Are pacemaker dependent (defined as a need for ventricular pacing = 20% of the time)
Have NYHA Class IV Heart Failure
Have persistent or permanent atrial fibrillation
Have a known history of intermittent Bundle Branch Block
Pregnant or planning a pregnancy during the study participation
Have a life expectancy of < 1 year due to any condition
Are currently participating in a clinical investigation that includes an active treatment arm
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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