NCT03016754

Heart Failure Optimization Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 602 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Sudden Cardiac Death
• Sudden Cardiac Arrest
• Heart Failure
• Heart Failure Low Output

Interventions

Type	Name	Description
DEVICE	Wearable Cardioverter Defibrillator	LifeVest is the brand of Wearable Cardioverter Defibrillator used in this study.

Timeline

• Start date: 2017-03-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2017-01-11
• Last updated: 2025-03-24
• Results posted: 2025-03-24

Locations

67 sites across 4 countries: United States, Austria, France, Germany