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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:9/20/2018
Start Date:July 13, 2018
End Date:July 31, 2022
Contact:Kathleen Graham
Email:kathleen.a.graham@medtronic.com
Phone:651-788-1645

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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.


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
We found this trial at
1
site
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Sitaramesh Emani, MD
Phone: 614-293-8962
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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