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Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure | Clinical Trials | Clareo Health

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Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

NCT04452149•Medtronic Cardiac Rhythm and Heart Failure

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient has NYHA Class II or III heart failure per most recent assessment, irrespective of left ventricular ejection fraction (LVEF)
•Patient has documented recent history of symptomatic heart failure, defined as meeting any one of the following three criteria: 1. Hospital admission with primary diagnosis of HF within the last 12 months, OR 2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration within the last 6 months, OR 3. Patient had the following BNP/NT-proBNP within the last 3 months: If LVEF ≥ 50%, then BNP\> 150 pg/ml or NT-proBNP \> 450 pg/ml OR If LVEF is \<50%, then BNP\> 300 pg/ml or NT-proBNP \> 900 pg/ml
•Patient is willing and able to comply with the protocol, including LINQ ICM insertion, CareLink transmissions (including adequate connectivity), study visits and remote care directions.
•Patient is 18 years of age or older.
•Patient has a life expectancy of 12 months or more.

Exclusion Criteria

•Patient is currently implanted with a cardiovascular implantable electronic device (CIED) (e.g. ICM, pacemaker, ICD, CRT-D or CRT-P device) or hemodynamic monitor.
•Patient is receiving temporary or permanent mechanical circulatory support.
•Patient had MI or PCI/CABG within past 90 days.
•Patient has had a heart transplant, or is currently on heart transplant list.
•Patient has severe valve stenosis on echocardiogram.
•Patient has primary pulmonary hypertension (pre-capillary, WHO group 1,3,4,5).
•Patient is on chronic intravenous inotropic drug therapy (e.g. dobutamine, milrinone).
•Patient has severe renal impairment (eGFR \<30 mL/min).
•Patient has systolic blood pressure of \< 90 mmHg at the time of enrollment.
•Patient is on chronic renal dialysis.
+9 more criteria

Locations (53)

Cardiovascular Associates of Mesa

Mesa, Arizona, United States

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Saint Joseph Heritage Healthcare

Mission Viejo, California, United States

Cardiology Associates Medical Group

Oxnard, California, United States

Saint Joseph's Medical Center

Stockton, California, United States

South Denver Cardiology Associates

Littleton, Colorado, United States

FWD Clinical Research LLC

Boca Raton, Florida, United States

Bay Area Cardiology Associates PA

Brandon, Florida, United States

Florida Heart Center

Ft. Pierce, Florida, United States

Baptist Health

Jacksonville, Florida, United States

Key Dates

Start Date

September 3, 2020

Primary Completion Date

June 2, 2025

Completion Date

June 2, 2025

Last Updated

January 13, 2026

Enrollment

826

ACTUAL participants

Conditions

Heart Failure NYHA Class IIHeart Failure NYHA Class III

Interventions

Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download

DEVICE

Medication intervention

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

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