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

Medtronic

Status

Completed

Conditions

Heart Failure

Treatments

Device: Investigational LINQ™ HF RAMware

Study type

Interventional

Funder types

Industry

Identifiers

NCT03608826

ReLINQuish

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No 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