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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608826
• Other study ID #: ReLINQuish
• Status: Completed
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: May 7, 2021

Study information

• Verified date: December 2022
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Characterization of the Changes in Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) Prior to Any Acute Decompensated Heart Failure Events.	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	Characterization of the Changes in Reveal LINQ™ Activity (Units of Hours Per Day) Prior to Any Acute Decompensated Heart Failure Events.	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	18 months