Stockton, California 95204

  • Heart Failure NYHA Class III

Purpose:

The ALLEVIATE-HF study is a prospective, randomized, multi-site, interventional, investigational device exemption (IDE) study. The purpose of the study is to gain experience with utilization of an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure.


Study summary:

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 300 subjects at up to 30 sites in the US, and will characterize the safety of the patient management pathway. Subjects will be followed for a minimum of 7 months, and until study closure.


Criteria:

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-proBNP6 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. ICM6, 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 (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment). - Patient is enrolled in another interventional study.


NCT ID:

NCT04452149


Primary Contact:

Principal Investigator
Javed Butler, MD
University of Mississippi Medical Center

Aimee Laechelt
Phone: (+1-763) 526-2730
Email: aimee.a.laechelt@medtronic.com


Backup Contact:

N/A


Location Contact:

Stockton, California 95204
United States

Cyrus Buhari, M.D.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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