Heart Failure Optimization Study

Study Overview
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Brief Summary
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This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved. Although the study doesn't start until day 90, all eligible, consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator (WCD) use. The pre-study registry will allow us to collect early (90 day) outcomes and data in those patients who are likely to be eligible for the study at day 90, or are eligible, but refuse the study at day 90.

Detailed Description
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This study will be conducted at thirty to sixty sites, initially in US and Europe. It will be used to observe the rate of recovery of ventricular function (EF>35%) between 90 and 180 days in newly diagnosed HF patients who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or non-ischemic cardiomyopathy, and have already used a WCD for 90 ± 14 days. For the first 90 days of WCD use, patients will be enrolled in a pre-study registry. The FDA-approved WCD will be prescribed for up to 6 months of use after hospital discharge, with the option for longer use under physician discretion. Approximately 870 subjects will enroll into the pre-study registry and 750 subjects into the study.

Official Title
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Heart Failure Optimization Study

Conditions
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Sudden Cardiac Death, Sudden Cardiac Arrest, Heart Failure, Heart Failure Low Output

Intervention / Treatment
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* Device: Wearable Cardioverter Defibrillator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Part 1 Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or nonischemic cardiomyopathy, and have used the WCD for no more than 30 days. Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if performed multiple times). Part 2 Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or nonischemic cardiomyopathy, and have already used a WCD for 90 ± 14 days. Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if performed multiple times). Of note, EF at 90 ± 14 days post-hospitalization does not need to be low to be included in the study. Exclusion Criteria: Patients under 18 years old. Patients who have an active unipolar pacemaker. Patients with a physical or mental condition that could impair their ability to properly interact with the device. Patients currently participating in another clinical study. Patients with any skin condition that would prevent wearing the device. Patients with an advanced directive prohibiting resuscitation. Patients who are indicated for cardiac resynchronization therapy or have a QRS duration of ≥135 ms. Patients with recent myocardial infarction or coronary revascularization (since start of WCD wear; i.e. 0-90 days of WCD wear).

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: Wearable Cardioverter Defibrillator|LifeVest Wearable Cardioverter Defibrillator|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Do not require ICD implant | Patient improved (EF >35%), SCD risk deemed to be negligible. These patients will end WCD use and not receive an ICD. | 180 days | 
| Continue WCD use | Patient improved EF from start of WCD use (a positive change of at least 5 percentage points in EF), or has a borderline EF of 30-35%, but still has continued SCD risk (EF ≤ 35%). These patients are expected to continue to use the WCD for an additional 3 months. | 180 days | 
| Meet GDMT | Patient not improved from start of WCD use (no change or worsening of EF), EF<30% and has continued high SCD risk. These patients will either continue the WCD for an additional 90 days if not on GDMT, or receive an ICD if already on GDMT. | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of other arrhythmias | Observe the incidence of other arrhythmias during WCD use, such as asystole and supra-ventricular arrhythmias that are recorded by the device. | 180 days | 
| Determine the number of ICD treatment shocks | Collect ICD treatment data for those who receive an ICD, and evaluate for appropriateness as assessed by ECG recordings. | 180 days | 
| Efficacy in ventricular arrhythmias | Observe the effectiveness of the wearable defibrillator worn by this population in treating ventricular arrhythmias. Clinical outcomes data from any defibrillation or cardiac event will be collected, including device data on appropriate arrhythmia detection and shock delivery. | 180 days | 
| Mortality following hospital discharge | Evaluate the effect of wearable defibrillators on 90,180, 270, and 360-day mortality following discharge in HF patients. Assessment of survival will be made at these time points for those entered into the study. A mortality review will be conducted to group all deaths as cardiac or non-cardiac, and sudden or non-sudden. | 360 days | 
| Cost of healthcare utilization | Assess cost of healthcare utilization (emergency room visits, hospitalizations, doctor visits etc.) on all patients during the period of the study. | 360 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sudden cardiac death, SCD, sudden cardiac arrest, SCA, heart failure, HF