Reveal LINQ™ Heart Failure

Reveal LINQ™ Heart Failure

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.

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 LINQ™ HF study is a Non-Significant Risk Investigational Device Exemption (IDE) study. The study is utilizing the Reveal LINQ™ device with an investigational LINQ™ HF RAMware download.

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):

  1. Admission with primary diagnosis of HF within the last 6 months, OR

  2. 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

  3. 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)