PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Device: Cardiac Resynchronization Therapy Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet the ICD indications Patients with Class III or IV heart failure. Patients receiving or who received a Medtronic CRT ICD within the previous 3 months. Patient must sign and date informed consent, and be 18 years of age or greater. Patient must be available for follow up visits, and be willing and able to comply with study protocol. Exclusion Criteria: Patient with acute myocardial infarction (MI), coronary artery bypass graft surgery (CABG) or percutaneous coronary angioplasty (PTCA)/stent within the last month. Patient with a mechanical right heart valve. Patient with chronic (permanent) atrial arrhythmias. Patient with life expectancy of less than 12 months. Patient with status post heart transplant Patient undergoing kidney dialysis Patients enrolled in a concurrent study that may confound the results of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiac Resynchronization Therapy Device|Patients with an ICD indication, a CRT indication and symptomatic heart failure who are implanted with a Cardiac Resynchronization Therapy Device.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From 6 month to the 12 month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 month to the 12 month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Congestive, Implantable Cardioverter-Defibrillators