Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.
NCT01779856 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81
Last updated 2021-02-15
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.
Conditions
Interventions
- DEVICE
-
REVEAL Insertable Cardiac Monitor (ICM)
Sponsors & Collaborators
-
Medtronic Corporate Technologies and New Ventures
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2015-07-31
- Completion
- 2015-09-30
- FDA Device
- Yes
Countries
- United States
- India
Study Locations
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