The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart failure related adverse events and health care utilization.
Study Type
OBSERVATIONAL
Enrollment
1,024
Patients with an ICD indication, a CRT indication and symptomatic heart failure who are implanted with a Cardiac Resynchronization Therapy Device.
Occurrence of Heart Failure (HF) Related Adverse Event (AE)
Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject's worsening HF or related to the heart's inability to meet the metabolic demands of the body.
Time frame: From 6 month to the 12 month visit
Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)
Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event.
Time frame: 6 month to the 12 month visit
Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)
Number of participates with HF related pulmonary congestion event will be reported. Time to the first HF related pulmonary cogestion event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups to see if there is significant difference. A HF related pulmonary congestion event is defined as hospitalization with signs and/or symptoms of pulmonary congestion, or outpatient treatment with IV diuretics due to exacerbation of HF with signs and/or symptoms of pulmonary congestion.
Time frame: 6 month to the 12 month visit
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Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Loma Linda, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
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Guilford, Connecticut, United States
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Bradenton, Florida, United States
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Fort Lauderdale, Florida, United States
...and 83 more locations