Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-03 @ 7:21 PM
Study NCT ID:
NCT02481206
Status:
TERMINATED
Last Update Posted:
2021-01-19
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
Sponsor:
Zoll Medical Corporation
Organization:
Study Overview
Official Title:
Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
Status:
TERMINATED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of subject enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WED-HED
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: