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Heart Failure Optimization Study

NCT03016754 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 602

Last updated 2025-03-24

Study results available
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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.

Conditions

Interventions

DEVICE

Wearable Cardioverter Defibrillator

LifeVest is the brand of Wearable Cardioverter Defibrillator used in this study.

Sponsors & Collaborators

  • Zoll Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Mike Osz · Director, Clinical Operations

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • United States
  • Austria
  • France
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03016754 on ClinicalTrials.gov