NCT02481206

Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of treatment and control. This study will evaluate the impact of wearable cardioverter defibrillator use on sudden cardiac death in incident hemodialysis patients. The study will enroll up to 2,600 subjects. A maximum of 200 sites in the USA will be used for enrollment.

Detailed description

Objective: To study the impact of wearable cardioverter defibrillator (WCD) use on sudden cardiac death in hemodialysis patients. Study Population: Participants will be patients beginning hemodialysis (\<2 months from initiation) who are ≥ 50 years old. Intervention: A WCD will be used for protection against sudden cardiac death (SCD). Study Design: The study will be a multi-center, prospective, randomized controlled trial with 1:1 assignment of treatment and control. Study Size: The study will enroll up to 2,600 subjects. A maximum of 200 sites will be used for enrollment.

Conditions

• Sudden Cardiac Death
• Sudden Cardiac Arrest

Interventions

Type	Name	Description
DEVICE	Wearable Cardioverter Defibrillator	Wearable Cardioverter Defibrillator

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-06-25
• Last updated: 2021-01-19
• Results posted: 2021-01-19

Locations

31 sites across 1 country: United States