Relationship Between LINQ™ Subcutaneous Impedance and Right-sided Hemodynamic Measurements
NCT ID: NCT03608826
Last Updated: 2022-12-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2018-07-13
2021-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single Arm Study
Invesigational RAMware will be downloaded onto the LINQ device.
Investigational LINQ™ HF RAMware
The Reveal LINQ™ device and the 2090 programmer are market-released, but once the investigational LINQ™ HF RAMware is downloaded into the devices, they are considered investigational.
Interventions
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Investigational LINQ™ HF RAMware
The Reveal LINQ™ device and the 2090 programmer are market-released, but once the investigational LINQ™ HF RAMware is downloaded into the devices, they are considered investigational.
Eligibility Criteria
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Inclusion Criteria
* Patients with symptomatic systolic or diastolic heart failure who in the clinician's judgment have a high likelihood of undergoing serial right heart catheterizations to aid in clinical management of their heart failure
* Patients with dyspnea on exertion in whom exercise hemodynamics is indicated to diagnose diastolic dysfunction
* Patients who have or will be implanted with a pulmonary artery pressure monitor
* Patient is 18 years of age or older
* Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
* Patient is willing and able to comply with the protocol, including follow-up visits and Carelink transmissions.
Exclusion Criteria
* Patient has a left ventricular assist device (LVAD)
* Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
* Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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Ohio State University
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ReLINQuish
Identifier Type: -
Identifier Source: org_study_id