Heart Failure; With Decompensation
Conditions
Brief summary
To conduct a prospective, observational study to evaluate the non-interventional feasibility of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.
Detailed description
To conduct a prospective, observational study to evaluate the non-interventional feasibility of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation. Participants will be adult (age ≥ 18 years) heart failure patients with an ejection fraction (EF) ≤ 35% and eligible to wear the WCD for at least 3 months. An FDA-approved WCD will be prescribed for at least 3 months of use after hospital discharge. This is a multi-center, prospective, observational study. The study will enroll a total of 300 subjects, anticipating that at least 250 subjects will complete the study. A maximum of 50 sites will enroll patients into the study.
Interventions
DEVICEWearable Cardioverter Defibrillator (WCD)
Observe and compare the heart sound measurements recorded by the WCD
Sponsors
Zoll Medical Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are prescribed the WCD ≤ 10 days post-discharge after hospitalization with Heart Failure (HF), with and ischemic or non-ischemic cardiomyopathy. * Patients who have an ejection fraction (EF) ≤ 35% at the time of WCD prescription. * Patients are anticipated to wear the WCD for at least 3 months. * The subject must be 18 years of age or older on the day of screening.
Exclusion criteria
* Patients with pacemakers, an implanted cardioverter defibrillator (ICD), or a cardiac resynchronization therapy device. * Patients waiting for heart transplant. * Patients with known evidence of atrial fibrillation on their most recent ECG recording. * Patients currently hospitalized for acute myocardial infarction. * Patients with a planned revascularization within 30 days of screening. * Patients who are self-reporting to be pregnant. * Patients participating in another clinical study. * Patients not expected to live longer than 1 year. * For patients in the United States, those who are unable or unwilling to provide written informed consent in English. * For patients in Europe, those who are unable or unwilling to provide written informed consent in their country specific language or English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observe the changes in the heart sounds measurement | 3 months | Observe the changes in the heart sounds measurement (recorded by the WCD) with clinical evidence of heart failure decompensation during the three month WCD treatment period. |
Countries
Austria, Germany, Poland, United States
Outcome results
None listed