LINQ Sensor Algorithm for Heart Failure
(ALLEVIATE-HF Trial)

Recruiting in Palo Alto (17 mi)

+59 other locations

Overseen ByJaved Butler, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Trial Summary

What is the purpose of this trial?This trial tests a small device that monitors heart activity in patients with moderate heart failure. The device uses special software to help doctors manage patient care more effectively.

Eligibility Criteria

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.

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

I am 18 years old or older.

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.

I am not pregnant or breastfeeding, and I have a negative pregnancy test.

My liver is not functioning properly, with high enzyme or bilirubin levels.

I cannot tolerate a short-term increase in my water pill dosage.

My kidney function is severely impaired.

I have a heart condition like thickened heart muscle, stiff heart lining, or amyloid buildup.

I am on long-term kidney dialysis.

I have a severe narrowing of my heart valves.

I have high blood pressure in the lungs not caused by heart disease.

I have a complex heart condition that I was born with.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention ArmExperimental Treatment2 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 ArmPlacebo Group1 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.