NCT04452149: ALLEVIATE-HF

Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

Completed NA Last updated 13 January 2026

What this trial tests

NA trial testing Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download in Heart Failure NYHA Class II in 826 participants. Completed in 2 June 2025.

Timeline

3 September 2020

Primary endpoint
2 June 2025

2 June 2025

Quick facts

Lead sponsor	Medtronic Cardiac Rhythm and Heart Failure
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	826
Start date	3 September 2020
Primary completion	2 June 2025
Estimated completion	2 June 2025
Sites	53 locations across United States

Drugs / interventions tested

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

Conditions studied

• Heart Failure NYHA Class II — all drugs for Heart Failure NYHA Class II →
• Heart Failure NYHA Class III — all drugs for Heart Failure NYHA Class III →

Sponsor

Medtronic Cardiac Rhythm and Heart Failure — full company profile →

Who can join

18 and older, any sex, with Heart Failure NYHA Class II or Heart Failure NYHA Class III. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Digital Technologies to Support Better Outcome and Experience of Care in Patients with Heart Failure.
   McBeath KCC, Angermann CE, Cowie MR. · · 2022 · cited 31× · PMID 35486314 · DOI 10.1007/s11897-022-00548-z
2. Prediction of worsening heart failure events and all-cause mortality using an individualized risk stratification strategy.
   Zile MR, Koehler J, Sarkar S, Butler J. · · 2020 · cited 25× · PMID 33118331 · DOI 10.1002/ehf2.13077
3. A Novel Heart Failure Diagnostic Risk Score Using a Minimally Invasive Subcutaneous Insertable Cardiac Monitor.
   Zile MR, Kahwash R, Sarkar S, Koehler J, et al · · 2024 · cited 16× · PMID 37943225 · DOI 10.1016/j.jchf.2023.09.014
4. Heart Failure Remote Monitoring: A Review and Implementation How-To.
   Kobe EA, McVeigh T, Hameed I, Fudim M. · · 2023 · cited 16× · PMID 37834845 · DOI 10.3390/jcm12196200
5. INTERVENE-HF: feasibility study of individualized, risk stratification-based, medication intervention in patients with heart failure with reduced ejection fraction.
   Zile MR, Costanzo MRR, Ippolito EM, Zhang Y, et al · · 2021 · cited 12× · PMID 33527654 · DOI 10.1002/ehf2.13231
6. Personalized Intervention Strategy Based on a Risk Score Generated From Subcutaneous Insertable Cardiac Monitor: Results From Phase 1 of ALLEVIATE-HF.
   Kahwash R, Zile MR, Chalasani P, Bertolet B, et al · · 2024 · cited 8× · PMID 39392161 · DOI 10.1161/jaha.124.035501
7. Continuous risk monitoring and management of heart failure: Rationale and design of the ALLEVIATE-HF trial.
   Butler J, Kahwash R, Khan MS, Gerritse B, et al · · 2025 · cited 4× · PMID 39871510 · DOI 10.1002/ejhf.3595
8. Risk-Based Nurse-Managed Personalized Heart Failure Interventions: The ALLEVIATE-HF Trial.
   Butler J, Kahwash R, Khan MS, Zhang D, et al · · 2026 · cited 2× · PMID 42201288 · DOI 10.1016/j.jacc.2026.03.075