Reveal LINQ™ Heart Failure

Completed

Conditions studied: Heart Failure

In brief

The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients with heart failure by assessing the relationship between changes in LINQ™ derived data and other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.

Key facts

Study ID

NCT02758301

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

112

Starts

2016-06-08

Expected to finish

2018-12-04

Last updated by the study team

2019-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Patient is NYHA Class III, per most recent assessment or at any time within 30 days prior to enrollment
• Patient had a HF event (HF event defined as meeting any one of the following three criteria):
• Admission with primary diagnosis of HF within the last 6 months, OR
• Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings within the last 6 months:
• Admission with secondary/tertiary diagnosis of HF
• Emergency Department
• Ambulance
• Observation Unit
• Urgent Care
• HF/Cardiology Clinic
• Patient's Home, OR
• Patient had the following BNP/NTpro-BNP within the last 3 months: If EF ≥ 50%, then BNP> 200 pg/ml or NTpro-BNP > 400 pg/ml OR If EF <50%, then BNP> 400 pg/ml or NTpro-BNP > 800 pg/ml

You may not qualify if…

• 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
• Patient has severe valvular heart disease as defined by hemodynamically significant valve stenosis and/or prosthetic heart valve
• Patient has existing IPG, ICD, CRT-D or CRT-P device
• Patient has severe renal impairment (eGFR <25mL/min)

Where it is running

• Scripps Green Hospital — La Jolla, California, United States
• Bay Area Cardiology Associates PA — Brandon, Florida, United States
• Prairie Education & Research Cooperative — Springfield, Illinois, United States
• Louisiana State University — New Orleans, Louisiana, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• CentraCare Heart & Vascular Center — Saint Cloud, Minnesota, United States
• Cardiology Associates of North Mississippi — Tupelo, Mississippi, United States
• Mid America Heart Institute — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Lourdes Cardiology Services — Voorhees Township, New Jersey, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• The Lindner Research Center — Cincinnati, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Oregon Health & Science University Hospital — Portland, Oregon, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• Austin Heart PA — Austin, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Centra Medical Group Stroobants Cardiovascular Center — Lynchburg, Virginia, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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