CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 602 enrolled
Drug / intervention
Wearable Cardioverter Defibrillatordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03016754
NCT03016754N/ACompleted
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Heart Failure Optimization Study

Zoll Medical Corporation·observational·Posted Jan 11, 2017·Updated Mar 24, 2025

In Brief

An observational study evaluating Wearable Cardioverter Defibrillator for Sudden Cardiac Death and 3 related conditions. Completed, enrolled 602 participants across 67 sites in 4 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSudden Cardiac Death, Sudden Cardiac Arrest, Heart Failure, Heart Failure Low Output
CountriesAustria, France, Germany, United States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 11, 2017
Enrollment StartMar 1, 2017
Primary CompletionJun 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 9.5 years ago

Interventions

Wearable Cardioverter Defibrillatordevice

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