N/A
N=602
Heart Failure Optimization Study
Sudden Cardiac Death · Sudden Cardiac Arrest · Heart Failure · Heart Failure Low Output
Bottom Line
View on ClinicalTrials.gov: NCT03016754 ↗Enrolled (actual)
602
Serious AEs
0.2%
Results posted
Mar 2025
Primary outcome: Primary: Percentage of Patients With LVEF Recovery at Day 90 and 180 — 222; 0; 0; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Wearable Cardioverter Defibrillator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zoll Medical Corporation
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With LVEF Recovery at Day 90 and 180 |
222; 0; 0; 0; 186; 79 | — |
| PRIMARY Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT) |
57; 36; 16; 164; 149; 63 | — |
| SECONDARY All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use |
4; 1; 0; 0 | — |
| SECONDARY All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use |
5; 1; 0; 0 | — |
| SECONDARY Percentage of All Patients Having Other Arrhythmias |
0; 1; 0; 0; 0; 1 | — |
| SECONDARY Efficacy in Treating Ventricular Arrhythmias |
7; 0 | — |
| SECONDARY Mortality Analysis |
2; 1; 1; 0; 1; 0 | — |
| SECONDARY Healthcare utilization_type |
2640; 247; 125; 21; 16; 81 | — |
| SECONDARY Healthcare utilization_length of Use |
3; 1; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
Phase 1 (Registry phase)
- 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).
Phase 2 (Study phase)
- Patients who completed Phase 1 and used a WCD for 90 ± 14 days.
Exclusion Criteria (both phases):
- 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.
Exclusion criteria (Phase 2)
- Patients who have a QRS duration of ≥135 ms and are planned for cardiac resynchronization therapy.
- Patients with recent myocardial infarction or coronary revascularization (since start of WCD wear; i.e. 0-90 days of WCD wear).
Data sourced from ClinicalTrials.gov (NCT03016754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.