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Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

NCT04452149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 826

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Javed Butler, MD · Baylor Scott and White Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2025-06-02
Completion
2025-06-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04452149 on ClinicalTrials.gov