Screening for Advanced Heart Failure Treatment (SEE-HF)

Study Overview
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Brief Summary
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Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.

Official Title
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Screening for Advanced Heart Failure Treatment (SEE-HF)

Conditions
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Advanced Heart Failure, CRT and/or ICD

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CRT and or ICD device in place. NYHA class III - IV heart failure EF </= 40% Patient is an out-patient Patient is on optimal medical management as tolerated and as defined by primary care physician. Patient has signed an informed consent for data collection. Exclusion Criteria: Age <18 years or >80 years CRT device that has been implanted < 3 months prior to enrollment Coronary revascularization within 3 months prior to enrollment Patient only has ICD but has CRT planned Non-cardiac disease resulting in life expectancy < 2 yrs Patient is hospitalized or will be hospitalized at this time Known diagnosis of dementia Patient is currently on dialysis Oxygen dependent lung disease Previously or currently treated with LVAD or heart transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients enrolled<br>All patients enrolled in the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients | Proportion of heart failure patients followed in outpatient clinic that are NYHA III-IV with LVEF </= 40% and a CRT and/or ICD who have an indication without contraindication for heart transplantationi and/or DT LVAD. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for non-referral | Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation. | 12 months | 
| Patient's reasons | Assess patients reasons for declining LVAD/transplant as a treatment option. | 12 months | 
| Actual and predicted 12 month survival | Assess the actual and predicted 12 month survival (predicted by VO2, the Heart Failure Survival Score (HFSS) and the Seattle Heart Failure Model (SHFM)). | 12 months | 
| Simple clinical parameters for referral | Identify simple clinical parameters that can be used by physicians to refer patients for LVAD/transplant evaluation at an optimal time. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoratec Corporation