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NCT03016754 · ClinicalTrials.gov registry record
Heart Failure Optimization Study
A clinical trial, sponsored by Zoll Medical Corporation.
- Completed
- Registry status
- 602
- Enrollment target
NCT03016754: Completed study, sponsored by Zoll Medical Corporation.
NCT03016754 is a clinical trial that has completed, run by Zoll Medical Corporation. The registered enrollment target is 602 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03016754 has completed, sponsored by Zoll Medical Corporation.
- COMPLETED
- Registry status
- 602 participants
- Enrollment target
Study 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.
Primary Outcome
The percentage of patients reaching the goal of LVEF\>35% will be compared at 90 days and 180 days. Echocardiographic assessment of LVEF was used.
Interventions
- DEVICE Wearable Cardioverter Defibrillator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2022-06-01 |
What the finished NCT03016754 record still lists
NCT03016754 is an observational study that tracks outcomes without assigning an intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Wearable Cardioverter Defibrillator is the first listed.
NCT03016754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03016754 about?
NCT03016754 is a clinical study titled "Heart Failure Optimization Study". 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 d...
What is the current status of trial NCT03016754?
This trial is currently completed. The enrollment target is 602 participants. The study started on 2017-03-01. Estimated completion is 2022-06-01.
What interventions are being tested in trial NCT03016754?
The interventions under investigation include: Wearable Cardioverter Defibrillator (DEVICE).
Who is sponsoring clinical trial NCT03016754?
This trial is sponsored by Zoll Medical Corporation, which has 24 total clinical trials registered on ClinicalTrials.gov.
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