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Relationship Between LINQ™ Subcutaneous Impedance and Right-sided Hemodynamic Measurements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03608826
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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Brief Summary:
The purpose of the ReLINQuish study is to characterize the relationship between subcutaneous impedance and hemodynamic measurements in patients with heart failure. Additionally, the relationship between changes in subcutaneous impedance and other physiologic parameters during acute decompensated HF events will be characterized.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Investigational LINQ™ HF RAMware Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Relationship Between LINQ™ Subcutaneous Impedance and Right-sided Hemodynamic Measurements
Actual Study Start Date : July 13, 2018
Actual Primary Completion Date : May 7, 2021
Actual Study Completion Date : May 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm Study
Invesigational RAMware will be downloaded onto the LINQ device.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of Reveal LINQ™ subcutaneous impedance (units of Ohms) with pulmonary artery pressure (units of mmHg) from a Swan-Ganz catheter during right heart catheterization procedures in patients with heart failure. [ Time Frame: 18 months ]
  2. Comparison of Reveal LINQ™ subcutaneous impedance (units of Ohms) with right atrial pressure (units of mmHg) from a Swan-Ganz catheter during right heart catheterization procedures in patients with heart failure. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Characterization of the changes in Reveal LINQ™ subcutaneous impedance (units of Ohms) prior to any acute decompensated heart failure events. [ Time Frame: 18 months ]
  2. Characterization of the changes in Reveal LINQ™ activity (units of hours per day) prior to any acute decompensated heart failure events. [ Time Frame: 18 months ]

    A heart failure event is defined as any cardiovascular-related (including hypervolemia) Health Care Utilizations (HCUs) for any one of the following events.

    • Admission with primary diagnosis of HF

    • Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings:

      • Admission with secondary/tertiary diagnosis of HF
      • Emergency Department
      • Ambulance
      • Observation Unit
      • Urgent Care


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients meeting at least 1 of 3 criteria will be included in the study:

    • 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 an existing Medtronic implantable cardiac device
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608826


Locations
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United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
More Information
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03608826    
Other Study ID Numbers: ReLINQuish
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases