NCT01326624

Study of the Wearable Defibrillator in Heart-Failure Patients

Study of the Wearable Defibrillator In Heart-Failure Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a high-risk for sudden cardiac death but are either not eligible for an implantable defibrillator under current guidelines or are not able to receive the device due to their condition.

Conditions

• Heart Failure
• Ventricular Dysfunction
• Sudden Death
• Sudden Cardiac Arrest
• Ventricular Tachycardia
• Ventricular Fibrillation

Interventions

Type	Name	Description
DEVICE	wearable defibrillator (LifeVest)	LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation

Timeline

• Start date: 2011-03-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2011-03-31
• Last updated: 2017-12-06

Locations

2 sites across 2 countries: United States, Israel