NCT02149290

LifeVest Trends Validation Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 198 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the accuracy of data on body position, daily activity, heart rate, 6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator (WCD).

Detailed description

This is a multi-center validation study of heart failure patients wearing the LifeVest WCD modified to collect data on body position, activity, heart rate, 6-minute walk test, and a health survey in order to evaluate data accuracy and patient interactions with the device.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Trends-equipped LifeVest 4000	LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-05-29
• Last updated: 2020-08-31
• Results posted: 2020-08-31

Locations

21 sites across 3 countries: United States, Austria, Germany

Regulatory

• FDA-regulated device study