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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure (Industry)

Overall Status

Completed

CT.gov ID

NCT03608826

Collaborator

(none)

Enrollment

Location

Arm

33.8

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jul 13, 2018

Actual Primary Completion Date :

May 7, 2021

Actual Study Completion Date :

May 7, 2021

Arms and Interventions

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.

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

Primary Outcome Measures

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. [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. [18 months]

Secondary Outcome Measures

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]
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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medtronic Cardiac Rhythm and Heart Failure

ClinicalTrials.gov Identifier:

NCT03608826

Other Study ID Numbers:

ReLINQuish

First Posted:

Aug 1, 2018

Last Update Posted:

May 16, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of May 16, 2022