NCT03203629

Heart Sounds Registry

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 705 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure; With Decompensation

Interventions

Type	Name	Description
DEVICE	Wearable Cardioverter Defibrillator (WCD)	Observe and compare the heart sound measurements recorded by the WCD

Timeline

• Start date: 2017-06-05
• Primary completion: 2020-01-30
• Completion: 2021-03-16
• First posted: 2017-06-29
• Last updated: 2021-04-23

Locations

33 sites across 4 countries: United States, Austria, Germany, Poland

Regulatory

• FDA-regulated device study