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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialysis patients | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous cardiac monitoring device (REVEAL, Medtronic) | Device | hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Significant Arrhythmia Detected | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Duke hemodialysis patients with end stage renal disease
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| Name | Affiliation | Role |
|---|---|---|
| Sana Al-Khatib, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11794197 | Background | Huikuri HV, Castellanos A, Myerburg RJ. Sudden death due to cardiac arrhythmias. N Engl J Med. 2001 Nov 15;345(20):1473-82. doi: 10.1056/NEJMra000650. No abstract available. | |
| 17540194 | Background | Al-Khatib SM, Sanders GD, Bigger JT, Buxton AE, Califf RM, Carlson M, Curtis A, Curtis J, Fain E, Gersh BJ, Gold MR, Haghighi-Mood A, Hammill SC, Healey J, Hlatky M, Hohnloser S, Kim RJ, Lee K, Mark D, Mianulli M, Mitchell B, Prystowsky EN, Smith J, Steinhaus D, Zareba W; Expert panel participating in a Duke's Center for the Prevention of Sudden Cardiac Death conference. Preventing tomorrow's sudden cardiac death today: part I: Current data on risk stratification for sudden cardiac death. Am Heart J. 2007 Jun;153(6):941-50. doi: 10.1016/j.ahj.2007.03.003. |
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Patients recruited from June 2009 to August 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm: Hemodialysis Patients Implanted With REVEAL Device | adult hemodialysis patients without a prior history of cardiac arrhythmias continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm: Hemodialysis Patients Implanted With REVEAL Device | adult hemodialysis patients without a prior history of cardiac arrhythmias continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Significant Arrhythmia Detected | All patients enrolled were analyzed in this observational study. | Posted | Number | participants | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm: Hemodialysis Patients Implanted With REVEAL Device | adult hemodialysis patients without a prior history of cardiac arrhythmias continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up |
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This is the 1st study of an implantable cardiac monitor in HD patients. Despite minimally invasive device implantation,collaboration between cardiology and nephrology, a large population of available subjects, we were able to enroll only 8 patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Pun, MD, MHS | Duke University | 919-660-6865 | patrick.pun@duke.edu |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 16893702 | Background | Goldenberg I, Moss AJ, McNitt S, Zareba W, Andrews ML, Hall WJ, Greenberg H, Case RB; Multicenter Automatic Defibrillator Implantation Trial-II Investigators. Relations among renal function, risk of sudden cardiac death, and benefit of the implanted cardiac defibrillator in patients with ischemic left ventricular dysfunction. Am J Cardiol. 2006 Aug 15;98(4):485-90. doi: 10.1016/j.amjcard.2006.03.025. Epub 2006 Jun 19. |
| 12694343 | Background | Herzog CA. Cardiac arrest in dialysis patients: approaches to alter an abysmal outcome. Kidney Int Suppl. 2003 May;(84):S197-200. doi: 10.1046/j.1523-1755.63.s84.17.x. |
| 17699443 | Background | Herzog CA. Can we prevent sudden cardiac death in dialysis patients? Clin J Am Soc Nephrol. 2007 May;2(3):410-2. doi: 10.2215/CJN.01130307. Epub 2007 Mar 27. No abstract available. |
| 17151332 | Background | Lehrich RW, Pun PH, Tanenbaum ND, Smith SR, Middleton JP. Automated external defibrillators and survival from cardiac arrest in the outpatient hemodialysis clinic. J Am Soc Nephrol. 2007 Jan;18(1):312-20. doi: 10.1681/ASN.2006040392. Epub 2006 Dec 6. |
| Background | USRDS Annual Data Report. Bethesda: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2006. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias | all participants included | Posted | Number | participants | 6 months |
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| 0 |
| 8 |
| 0 |
| 8 |
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| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |