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

ZOLL Medical

Status

Terminated

Conditions

Sudden Cardiac Arrest

Sudden Cardiac Death

Treatments

Device: Wearable Cardioverter Defibrillator

Study type

Interventional

Funder types

Industry

Identifiers

NCT02481206

90D0126

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

End stage renal disease (ESRD) requiring hemodialysis
On hemodialysis for ≤ 2 calendar months or scheduled to begin hemodialysis within 1 calendar month
≥50 years of age
Documented Ejection Fraction > 35% within the previous calendar year
- If the patient has been hospitalized for a myocardial infarction or heart failure decompensation, the Ejection Fraction measurement must have occurred during the last hospitalization or after discharge

Exclusion criteria

Is receiving or will receive hemodialysis due to acute kidney injury and is not expected to receive subsequent chronic hemodialysis therapy
Patient has an active ICD
Patient has a unipolar pacemaker
Patient has physical or mental conditions preventing him/her from interacting with or wearing a Wearable Cardioverter Defibrillator
Patient has a chest circumference at the level of the xiphoid of < 24 inches
Patient has a chest circumference at the level of the xiphoid of > 56 inches
Patient has an advance directive prohibiting resuscitation
Patient has cancer or other terminal disease (excluding ESRD) with expected survival less than 6 months
Patient is medically unstable for reasons not specifically related to kidney disease
Patient is scheduled for live-donor kidney transplantation within 6 calendar months
Patient is unable to consent