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

NCT02481206 | Terminated Results DMC

• 1 other identifier: 90D0126
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 31

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.

Conditions

Sudden Cardiac Death; Sudden Cardiac Arrest

Keywords

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis

  This is an intention to treat analysis of SCD, with subjects analyzed by randomization assignment regardless of treatment crossovers or noncompliance. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate.

  6 months

Secondary Outcomes (8)

• Total Mortality

  6 months

• Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis

  6 months

• Clinical Status of Sudden Cardiac Arrest (SCA) Survivors

  48 hours after SCA

• Incidence of Potentially Life Threatening Arrhythmias

  6 months

• Risk of Inappropriate Therapy

  6 months

Study Arms (2)

Wearable Cardioverter Defibrillator

EXPERIMENTAL

End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months

Device: Wearable Cardioverter Defibrillator

Conventional Treatment

NO INTERVENTION

Conventional Treatment

Interventions

Wearable Cardioverter Defibrillator DEVICE

Wearable Cardioverter Defibrillator

Also known as: WCD, LifeVest

Wearable Cardioverter Defibrillator

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (31)

Unknown Facility

Corona, California, United States

Location

Unknown Facility

Downey, California, United States

Location

Unknown Facility

Escondido, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

San Dimas, California, United States

Location

Unknown Facility

San Luis Obispo, California, United States

Location

Unknown Facility

Whittier, California, United States

Location

Unknown Facility

Stamford, Connecticut, United States

Location

Unknown Facility

Hialeah, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Pembroke Pines, Florida, United States

Location

Unknown Facility

Winter Garden, Florida, United States

Location

Unknown Facility

Albany, Georgia, United States

Location

Unknown Facility

Columbus, Georgia, United States

Location

Unknown Facility

Fort Wayne, Indiana, United States

Location

Unknown Facility

Greenbelt, Maryland, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Rochester Hills, Michigan, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

New Brunswick, New Jersey, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Canton, Ohio, United States

Location

Unknown Facility

Greenville, South Carolina, United States

Location

Unknown Facility

Chattanooga, Tennessee, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Zoll

mosz@zoll.com

724-968-3333

Study Officials

• Wojciech Zareba, M.D., Ph.D

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Charles A. Herzog, M.D.

  Chronic Disease Research Group, Hennepin County Medical Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 25, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 19, 2021
• Results First Posted: January 19, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)