Relationship Between LINQ™ Subcutaneous Impedance and Right-sided Hemodynamic Measurements
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jul 2018
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2018
CompletedStudy Start
First participant enrolled
July 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2021
CompletedResults Posted
Study results publicly available
December 23, 2022
CompletedDecember 23, 2022
December 1, 2022
2.8 years
June 14, 2018
November 2, 2022
December 2, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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.
The primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure.
18 months
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.
The primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure.
18 months
Secondary Outcomes (2)
Characterization of the Changes in Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) Prior to Any Acute Decompensated Heart Failure Events.
18 months
Characterization of the Changes in Reveal LINQ™ Activity (Units of Hours Per Day) Prior to Any Acute Decompensated Heart Failure Events.
18 months
Study Arms (1)
Single Arm Study
EXPERIMENTALInvesigational RAMware will be downloaded onto the LINQ device.
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
No right heart catheterization was performed during the study, hence the primary outcome could not be summarized. The LINQ device data was not available prior to the acute decompensated heart failure events, hence the secondary outcome could not be summarized.
Results Point of Contact
- Title
- Nicole Wood
- Organization
- Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2018
First Posted
August 1, 2018
Study Start
July 13, 2018
Primary Completion
May 7, 2021
Study Completion
May 7, 2021
Last Updated
December 23, 2022
Results First Posted
December 23, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share