N/A
Completed N=12
Relationship Between LINQ™ Subcutaneous Impedance and Right-sided Hemodynamic Measurements
Source: ClinicalTrials.gov NCT03608826 ↗Enrolled (actual)
12
Serious AEs
33.3%
Results posted
Dec 2022
Primary outcomePrimary: 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. — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
— | — |
| 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. |
— | — |
| SECONDARY Characterization of the Changes in Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) Prior to Any Acute Decompensated Heart Failure Events. |
— | — |
| SECONDARY Characterization of the Changes in Reveal LINQ™ Activity (Units of Hours Per Day) Prior to Any Acute Decompensated Heart Failure Events. |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03608826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.