Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients

Completed

• Conditions: Arrhythmias, Cardiac
• Interventions: Device: continuous cardiac monitoring device (REVEAL, Medtronic)

• Registration Number: NCT00932659
• Lead Sponsor: Duke University

Brief Summary

Hemodialysis patients have a rate of fatal arrhythmias that is 40 times greater than the general population, but the causes and types of fatal arrhythmias they experience is unclear. The purpose of this prospective observational cohort study is to capture and characterize occult arrhythmias which occur in hemodialysis patients over a 6 month period. After informed consent and baseline assessment, 30 adult hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device (REVEAL, Medtronic). Three followup visits will be scheduled to download device data and quantify the number of potentially malignant arrhythmias which occur in study subjects during the 6 month period. Additionally, captured events will be monitored remotely via regular patient initiated transmission of device data every 2 weeks. Any serious occult arrhythmias detected will be immediately acted upon with a predefined management algorithm. Descriptive data and simple proportions will be used to describe the incidence and types of arrhythmias among the study cohort. Risks of this study include 1) potential loss of patient confidentiality 2) risks related to insertion of device including pocket hematoma, device infection, pain and discomfort secondary to procedure. These will be minimized by strict security measures to protect each patient's protected health information (PHI), preprocedural screening and insertion of monitoring devices by highly trained operators, and frequent careful direct patient followup.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-12-13
• Status Verified: 2013-02
• Results First Submitted QC: 2013-02-19
• Results First Posted: 2013-03-27
• Last Update Submitted: 2013-04-11
• Last Update Posted: 2013-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Greater than 18 years of age
• ESRD receiving hemodialysis for at least 3 months

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Exclusion Criteria

• Inability to give informed consent
• Pre-existing implantable cardiac device (pacemaker or ICD) or imminent device implantation
• Imminent renal transplantation
• Life expectancy < 1yr
• PT-INR or aPTT > 1.7 upper limit of normal (ULN) or history of bleeding diathesis
• Unstable medical condition as deemed by primary nephrologist or study staff
• Known sustained ventricular tachycardia due to non-reversible cause.
• Active infection
• Known atrial fibrillation
• Women who are pregnant

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemodialysis patients	continuous cardiac monitoring device (REVEAL, Medtronic)	This is a single arm observational study. The single arm consists of adult hemodialysis patients without a prior history of cardiac arrhythmias who will be implanted with a continuous cardiac monitoring device (REVEAL, Medtronic) for an FDA approved indication.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Significant Arrhythmia Detected	6 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias	6 months

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States