Heart Sounds Registry (HEARIT-Reg)

ZOLL Medical

Status: Completed

Conditions: Heart Failure; With Decompensation

Treatments: Device: Wearable Cardioverter Defibrillator (WCD)

Study type: Observational

Funder types: Industry

Identifiers

NCT03203629

90D0164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 705 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.