LINQ Sensor Algorithm for Heart Failure

(ALLEVIATE-HF Trial)

No longer recruiting at 62 trial locations

Overseen By Kelly Axsom, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Must not be taking: Inotropes

Disqualifiers: CIED, Mechanical support, MI, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing heart failure using the Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download. The goal is to determine if this device, combined with special software, can help doctors treat moderate heart failure more effectively. Participants will either have their care guided by this new technology or receive standard heart failure care. Those who have recently experienced heart failure symptoms, such as hospital visits or special treatments, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative heart failure management research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Reveal LINQ™ system is safe for heart failure patients?

Research shows that the Reveal LINQ™ Insertable Cardiac Monitor is generally safe. Studies have found that doctors can insert the device safely and easily in hospitals without needing a special lab or operating room, making the procedure simple and usually well-tolerated.

While the Reveal LINQ™ device is already on the market, this study tests new software called ALLEVIATE-HF RAMware. Direct safety data on this new software is limited, but the device it operates on is widely used and has no known issues with its wireless features.

Overall, existing data supports the device's safety, providing context for the safety of this new software. However, participants should always discuss any concerns with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard heart failure treatments, which typically involve medications like ACE inhibitors, beta-blockers, or diuretics, the Reveal LINQ™ Insertable Cardiac Monitor with ALLEVIATE-HF RAMware offers a novel approach by integrating a diagnostic-based risk stratification algorithm. This innovative technique allows for real-time monitoring and management of heart failure, potentially leading to more personalized and timely interventions. Researchers are excited because this method could improve patient outcomes by detecting heart failure risk earlier and providing data-driven guidance for medication adjustments.

What evidence suggests that the Reveal LINQ™ system is effective for heart failure?

In this trial, participants will receive the Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download. Studies have shown that this device effectively identifies patients with heart failure who are at risk of worsening symptoms. It uses a special program to analyze various heart signals and predict potential heart failure events. Early research suggests this can help doctors manage heart failure more effectively by adjusting treatments before symptoms worsen. The LINQ-HF study found that this method reliably monitors heart health over the long term. This could be a promising tool for people with heart failure to manage their condition better. Participants in the intervention arm will be managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan, while those in the observation arm will be managed per standard care without access to heart failure sensor data. ^{3 6 7 8 9}

Who Is on the Research Team?

Javed Butler, MD

Principal Investigator

Baylor Scott and White Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with NYHA Class II or III heart failure who have had recent symptoms or treatments for heart failure. They must expect to live at least another year, be able to follow the study protocol, and not be part of another interventional study. People with severe kidney issues, low blood pressure, certain heart conditions, active cancer treatment, or those on mechanical circulatory support cannot join.

Inclusion Criteria

I have had heart failure symptoms or treatment recently.

Patient has a life expectancy of 12 months or more.

I have moderate heart failure according to my latest check-up.

Exclusion Criteria

I am on long-term IV medication to strengthen my heart.

I have had a heart transplant or am on the waiting list for one.

I am currently receiving chemotherapy or radiation for my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Subjects receive a Reveal LINQ™ Insertable Cardiac Monitor and are managed per standard of care without visibility to sensor data

13 months

Intervention

Subjects are managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

7-13 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The ALLEVIATE-HF study tests a new patient management approach using an algorithm from LINQ sensors to guide care in heart failure patients. It also assesses the safety of Reveal LINQ™ monitors and procedures. Participants are randomly assigned to either receive this new intervention or continue with standard care.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 2 Interventions

Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan.

Group II: Observation Arm Placebo Group 1 Intervention

Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed per standard of care for heart failure management without visibility to the heart failure sensor data. Subjects will transition to the intervention arm after 13 months.

Who Is Running the Clinical Trial?

Medtronic Cardiac Rhythm and Heart Failure

Lead Sponsor

Trials

206

Recruited

137,000+

Geoff Martha

Medtronic Cardiac Rhythm and Heart Failure

Chief Executive Officer since 2020

MBA from University of Minnesota

Dr. Kweli Thompson

Medtronic Cardiac Rhythm and Heart Failure

Chief Medical Officer since 2022

MD from Harvard Medical School

Published Research Related to This Trial

The Reveal LINQ insertable cardiac monitor (ICM) demonstrated a high positive predictive value for detecting atrial fibrillation (AF), with values of 84% for all episodes and up to 97% for episodes lasting at least one hour in patients with syncope, known AF, and cryptogenic stroke, based on a study of 3759 patients.

The study found that limiting ECG storage to the longest detected AF episode reduced the workload for reviewing episodes without significantly affecting the detection of true AF cases, indicating an efficient monitoring strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world performance of an enhanced atrial fibrillation detection algorithm in an insertable cardiac monitor. Mittal, S., Rogers, J., Sarkar, S., et al.[2022]

The Biomon-HF project developed and tested innovative sensors for monitoring vital signs during sleep in 115 heart failure patients, showing promise for personalized telemonitoring and therapy management.

These sensors can help detect heart failure exacerbations and related health issues early, potentially reducing complications and healthcare costs while improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized biomonitoring in heart failure--Biomon-HF "Keep an eye on heart failure--especially at night". Vollmer, T., Schauerte, P., Zink, M., et al.[2015]

A study involving 28 heart failure patients demonstrated that smartphone-based monitoring, which combined passive data (like movement and social interactions) and active surveys, can effectively predict heart failure decompensation events, achieving a high accuracy with an AUC of 0.83 for a 2-day prediction window.

The findings suggest that social data, such as the frequency and duration of phone calls, can provide valuable insights into a patient's health status, indicating that smartphone monitoring could be a cost-effective alternative to traditional monitoring methods for heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passively Captured Interpersonal Social Interactions and Motion From Smartphones for Predicting Decompensation in Heart Failure: Observational Cohort Study. Cakmak, AS., Perez Alday, EA., Densen, S., et al.[2022]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jchf.2023.09.014

A Novel Heart Failure Diagnostic Risk Score Using ... The LINQ-HF clinical study was an observational study that collected ICM diagnostics data using an investigational ramware and HF event ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2213177923006236

A Novel Heart Failure Diagnostic Risk Score Using ... ICM-HFRS provides a multiparameter, integrated diagnostic method with the ability to identify when HF patients are at increased risk of heart failure events.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04452149

Study Details | NCT04452149 | Algorithm Using LINQ ... 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 ...

4. medtronic.com medtronic.com/en-us/healthcare-professionals/products/cardiac-rhythm/cardiac-monitoring/insertable-cardiac-monitors/reveal-linq-icm.html

Reveal LINQ™ Insertable Cardiac Monitor The Reveal LINQ™ ICM with AccuRhythm™ AI algorithms is for patients with infrequent symptoms requiring long-term cardiac monitoring.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01965899

Usability Study to Assess the Reveal LINQ Insertable ... The study will assess functionality of the Reveal LINQ device by assessing sensing performance and data transmission. Official Title. Reveal LINQ Usability ...

6. medtronic.com medtronic.com/uk-en/patients/treatments-therapies/heart-monitors/our-monitors/important-safety-information.html

Heart Monitors - Important Safety Information Patients with the Reveal LINQ Insertable Cardiac Monitor should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external ...

7. bmccardiovascdisord.biomedcentral.com bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-019-1106-3

Safety of in-hospital insertable cardiac monitor procedures ... Conclusions. The Reveal LINQ™ ICM insertion can be safely and efficiently performed in the hospital outside the cath/EP lab or OR. Trial ...

8. medtronic.com medtronic.com/en-us/l/isw/cardiac-monitors-indications-safety-warnings.html

Indications, Safety, & Warnings - Cardiac Monitors There are no known adverse events associated with the use of any LINQ II ICM wireless accessory. See the device manuals for detailed information regarding the ...

9. academic.oup.com academic.oup.com/europace/article/20/6/1050/4030795

Clinical impact, safety, and accuracy of the remotely monitored ... The remote monitoring feature of the Reveal LINQTM allowed earlier diagnosis of asymptomatic but serious arrhythmias in a significant proportion ...