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Clinical Trial Summary

The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (IDE) pivotal study. The purpose of the study is to demonstrate the safety and efficacy of a patient management pathway that utilizes an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure, and to demonstrate the safety of the Reveal LINQ™ system and procedure in the study population.


Clinical Trial Description

The study will utilize the market released Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download. The study will enroll up to 900 subjects at up to 75 sites in the US. Subjects will be followed until the last enrolled subject is followed for 7 months or until the end of the study, whichever occurs first, or until time of study exit or death as applicable, but no longer than 36 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04452149
Study type Interventional
Source Medtronic Cardiac Rhythm and Heart Failure
Contact Aimee Laechelt
Phone (+1-763) 267-8748
Email aimee.a.laechelt@medtronic.com
Status Recruiting
Phase N/A
Start date September 3, 2020
Completion date April 2025

See also
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