Heart Sounds Registry — HEARIT-Reg  

Heart Failure; With Decompensation Clinical Trial

Official title: Heart Sounds Registry In Patients Using The Wearable Cardioverter Defibrillator (HEARIT-Registry) Study Protocol

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure; With Decompensation

• NCT number: NCT03203629
• Study type: Observational [Patient Registry]
• Source: Zoll Medical Corporation
• Status: Completed
• Start date: June 5, 2017
• Completion date: March 16, 2021