NCT04452149

Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 826 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Failure NYHA Class II
• Heart Failure NYHA Class III

Interventions

Type	Name	Description
DEVICE	Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download	Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.
OTHER	Medication intervention	Risk status guided medication intervention.

Timeline

• Start date: 2020-09-03
• Primary completion: 2025-06-02
• Completion: 2025-06-02
• First posted: 2020-06-30
• Last updated: 2026-01-13

Locations

53 sites across 1 country: United States

Regulatory

• FDA-regulated device study