Introduction
The Clinical Investigation Plan provides an overview of the Reveal LINQ Heart Failure (HF) clinical study. The study aims to evaluate the safety and efficacy of the Reveal LINQ ICM in patients with heart failure.
Study Purpose
The primary objective of this study is to assess the effectiveness of the Reveal LINQ ICM in detecting cardiac rhythm disorders in patients with heart failure.
System Description and Intended Use
The Reveal LINQ ICM is a small, implantable device that records cardiac rhythm patterns. It is intended for use in patients with heart failure to monitor and detect cardiac rhythm disorders.
Components
The system consists of the Reveal LINQ ICM, an incision tool, an insertion tool, a 2090 programmer, Medtronic LINQ HF Investigational RAMware, a patient assistant, and a MyCareLink Home Monitor.
Methodology
The study will be conducted in accordance with Good Clinical Practice and applicable regulatory requirements. The study will involve the implantation of the Reveal LINQ ICM in patients with heart failure and the collection of data on cardiac rhythm patterns.
Enrollment and Follow-up
Patients will be enrolled in the study and followed up for a period of approximately 6 months. During this time, the Reveal LINQ ICM will transmit data to a remote monitor, and patients will undergo regular follow-up visits to monitor device performance and ensure patient safety.
Manual:
Download: Clinical Investigation Plan for Reveal LINQ Heart Failure (HF)
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