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Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis. | Clinical Trials | Clareo Health

COMPLETEDNA

Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.

Monitoring in Dialysis

NCT01779856•Medtronic Corporate Technologies and New Ventures

View on ClinicalTrials.gov

Summary

The primary objective of this study is to estimate the proportion of hemodialysis patients experiencing clinically significant cardiac arrhythmias over a 6-month period using continuous cardiac monitoring with an implanted Medtronic Reveal Insertable Cardiac Monitor (ICM) device.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•21 years of age or older and is willing to be implanted with the Reveal ICM
•Currently on hemodialysis at least three times per week OR has an estimated glomerular filtration rate (eGFR) of \< 15 mL/min/1.73m\^2 and is expected to begin hemodialysis within 2 months.
•Subject is willing and able to comply with the protocol

Exclusion Criteria

•Currently enrolled in an interventional study that may interfere with the Monitoring in Dialysis protocol
•Not suitable for Reveal ICM implantation
•Has an existing hemodialysis catheter that may interfere with the Reveal ICM implantation site
•Has a recent infection
•Is currently on hemodialysis with a hemoglobin \< 10 g/dL
•Has end-stage liver failure or has had thoracic surgery within the past 6 months
•Has an existing pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac resynchronization device
•Is scheduled for renal transplantation or will likely be transplanted within 6 months
•Is currently on home hemodialysis

Locations (10)

Augusta, Georgia, United States

Boston, Massachusetts, United States

Cincinnati, Ohio, United States

Chattanooga, Tennessee, United States

Houston, Texas, United States

Chennai, India

Gūrgaon, India

Hyderabad, India

New Delhi, India

Key Dates

Start Date

January 1, 2013

Primary Completion Date

July 1, 2015

Completion Date

September 1, 2015

Last Updated

February 15, 2021

Enrollment

ACTUAL participants

Conditions

End Stage Renal Disease

Interventions

REVEAL Insertable Cardiac Monitor (ICM)

DEVICE

EndoForce Post Approval Study

NCT07146854

End Stage Renal Disease (ESRD)

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RECRUITINGNA

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

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End Stage Renal DiseaseHypertension+2 more

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RECRUITINGPHASE2

Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.

Inclusion Criteria

Exclusion Criteria

EndoForce Post Approval Study

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD

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