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NCT03608826

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

Completed NA Results posted Last updated 23 December 2022
What this trial tests

NA trial testing Investigational LINQ™ HF RAMware in Heart Failure in 12 participants. Completed in 7 May 2021.

Timeline
13 July 2018
Primary endpoint
7 May 2021
7 May 2021

Quick facts

Lead sponsorMedtronic Cardiac Rhythm and Heart Failure
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment12
Start date13 July 2018
Primary completion7 May 2021
Estimated completion7 May 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medtronic Cardiac Rhythm and Heart Failure — full company profile →

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 18 months

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.

GroupValue95% CI
Observation0
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. Primary · 18 months

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.

GroupValue95% CI
Observation0
Characterization of the Changes in Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) Prior to Any Acute Decompensated Heart Failure Events. Secondary · 18 months

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.

GroupValue95% CI
Observation0
Characterization of the Changes in Reveal LINQ™ Activity (Units of Hours Per Day) Prior to Any Acute Decompensated Heart Failure Events. Secondary · 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

GroupValue95% CI
Observation0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected up to 18 months from enrollment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Arm
Serious: 4/12 (33%)
Deaths: 3/12

Serious adverse events (2 terms)

ReactionSystemSingle Arm
DeathCardiac disorders
HospitalizationCardiac disorders

Most-reported serious reactions: Death, Hospitalization.

Data from ClinicalTrials.gov NCT03608826 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Heart Failure

Currently open trials in the same condition.

Other Medtronic Cardiac Rhythm and Heart Failure trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03608826.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing