Status:
COMPLETED
Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure NYHA Class II
Heart Failure NYHA Class III
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Patient is unable to undergo one round of PRN medication intervention (i.e. 4 days of increased diuretics dose).
- Patient has liver disease, defined as AST/ALT \>5x normal, or bilirubin \>2x normal.
- Patient has serum albumin \< 3 g/dL.
- Patient has hypertrophic obstructive cardiomyopathy, constrictive pericarditis or amyloidosis.
- Patient has complex adult congenital heart disease.
- Patient has active cancer involving chemotherapy and/or radiation therapy.
- Patient weighs more than 500 pounds.
- Patient is pregnant or breastfeeding (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment).
- Patient is enrolled in another interventional study.
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2025
Estimated Enrollment :
826 Patients enrolled
Trial Details
Trial ID
NCT04452149
Start Date
September 3 2020
End Date
June 2 2025
Last Update
October 10 2025
Active Locations (53)
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1
Cardiovascular Associates of Mesa
Mesa, Arizona, United States, 85282
2
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72410
3
Saint Joseph Heritage Healthcare
Mission Viejo, California, United States, 92691
4
Cardiology Associates Medical Group
Oxnard, California, United States, 93030