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

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.

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