Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

Heart Failure NYHA Class III Clinical Trial

— ALLEVIATE-HF  

Official title:

Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04452149
• Other study ID #: ALLEVIATE-HF
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: Aimee Laechelt
• Phone: (+1-763) 267-8748
• Email: aimee.a.laechelt[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 the US. Subjects will be followed until the last enrolled subject is followed for 7 months or until the end of the study, whichever occurs first, or until time of study exit or death as applicable, but no longer than 36 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-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 Criteria:

• 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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III

Intervention

Device:
• Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.

Other:
• Medication intervention
Risk status guided medication intervention.

Locations

Country	Name	City	State
United States	New Mexico Heart Institute PA	Albuquerque	New Mexico
United States	FWD Clinical Research LLC	Boca Raton	Florida
United States	Bay Area Cardiology Associates PA	Brandon	Florida
United States	New York-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	Charleston Area Medical Center (CAMC) Memorial Hospital	Charleston	West Virginia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	The Lindner Research Center	Cincinnati	Ohio
United States	Missouri Cardiovascular Specialists	Columbia	Missouri
United States	Prisma Health Midlands	Columbia	South Carolina
United States	Mount Carmel East	Columbus	Ohio
United States	OhioHealth Research and Innovation Institute (OHRI)	Columbus	Ohio
United States	Doylestown Health Cardiology a division of Doylestown Health Physicians	Doylestown	Pennsylvania
United States	Saint Elizabeth Healthcare	Edgewood	Kentucky
United States	NorthShore University Health System	Evanston	Illinois
United States	Florida Heart Center	Fort Pierce	Florida
United States	Parkview Health	Fort Wayne	Indiana
United States	Medical City Fort Worth	Fort Worth	Texas
United States	The Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Cone Health	Greensboro	North Carolina
United States	Ascension Medical Group - Saint Vincent	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Baptist Health	Jacksonville	Florida
United States	First Coast Cardiovascular Institute PA	Jacksonville	Florida
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Citrus Cardiology Consultants PA	Leesburg	Florida
United States	CHI Health Nebraska Heart	Lincoln	Nebraska
United States	South Denver Cardiology Associates	Littleton	Colorado
United States	Baptist Healthcare System	Louisville	Kentucky
United States	Norton Healthcare	Louisville	Kentucky
United States	University of Tennessee Methodist Physicians	Memphis	Tennessee
United States	Cardiovascular Associates of Mesa	Mesa	Arizona
United States	Saint Joseph Heritage Healthcare	Mission Viejo	California
United States	West Virginia University	Morgantown	West Virginia
United States	Columbia University Irving Medical Center/NYPH	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	CHI Health Creighton University Medical Center - Bergan Mercy	Omaha	Nebraska
United States	Cardiology Associates Medical Group	Oxnard	California
United States	Baptist Hospital	Pensacola	Florida
United States	Cardiology Consultants of Philadelphia	Philadelphia	Pennsylvania
United States	Hudson Valley Heart Center	Poughkeepsie	New York
United States	North Memorial Health Heart & Vascular Center	Robbinsdale	Minnesota
United States	Saint Francis Hospital	Roslyn	New York
United States	Northside Hospital	Saint Petersburg	Florida
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Swedish Medical Center Cherry Hill	Seattle	Washington
United States	Advanced Cardiovascular Specialists	Shreveport	Louisiana
United States	Saint Joseph's Medical Center	Stockton	California
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Saint Joseph Medical Center (Tacoma WA)	Tacoma	Washington
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	Cardiology Associates of North Mississippi	Tupelo	Mississippi
United States	Tyler Cardiovascular Consultants	Tyler	Texas
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Lourdes Cardiology Services	Voorhees	New Jersey
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Novant Health New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events	The proportion of medication interventions with one or more associated medication intervention related SAEs will be evaluated.	Up to 3 years
Primary	Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire and change in six-minute walk test distance	Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status.	Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months
Secondary	Safety of Reveal LINQ™ system and procedure - Percentage of subjects experiencing system or procedure related serious adverse events	Freedom from Reveal LINQ™ system and procedure related serious adverse events at 6 months will be evaluated.	Up to 6 months post Reveal LINQ™ device insertion attempt
Secondary	Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire, change in six-minute walk test distance, and change in device-measured activity and night heart rate	Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status.	Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months