Heart Failure Clinical Trial
Reveal LINQâ„¢ Heart Failure
Summary
The purpose of the LINQâ„¢ HF study is to characterize Reveal LINQâ„¢ derived data from patients with heart failure by assessing the relationship between changes in LINQâ„¢ derived data and other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.
Full Description
The study is a prospective, non-randomized, multi-center, observational, pre-market clinical study. The study is expected to be conducted at up to 30 centers in the United States. Up to 300 subjects will be enrolled to achieve approximately 40 heart failure events (no more than two per subject will contribute to the cumulative total). Study subjects will be followed for up to 3 years post-insertion or until official study closure defined as when Medtronic and/or regulatory requirements have been satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, whichever occurs first. The expected study duration is approximately 4 years representing 1.5 years of enrollments and 2.5 years of follow-up.
The LINQâ„¢ HF study is a Non-Significant Risk Investigational Device Exemption (IDE) study. The study is utilizing the Reveal LINQâ„¢ device with an investigational LINQâ„¢ HF RAMware download.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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There are 19 Locations for this study
La Jolla California, 92037, United States
Brandon Florida, 33511, United States
Springfield Illinois, 62701, United States
New Orleans Louisiana, 70112, United States
Lansing Michigan, 48912, United States
Saint Cloud Minnesota, 56303, United States
Tupelo Mississippi, 38801, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63110, United States
Voorhees New Jersey, 08043, United States
Charlotte North Carolina, 28203, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97239, United States
Lancaster Pennsylvania, 17602, United States
Austin Texas, 78756, United States
Charlottesville Virginia, 22908, United States
Lynchburg Virginia, 24501, United States
Norfolk Virginia, 23507, United States
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