Heart Failure Clinical Trial
Official title:
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.
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