Clinical trial NCT04452149: Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
Official title: Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure NYHA Class II
Heart Failure NYHA Class III
Keywords: Heart Failure
Insertable Cardiac Monitor
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2020-06-30
Enrollment: 826
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following Reveal LINQ™ device insertion, subjects will be randomly allocated in a blinded fashion in a 1:1 ratio to either the observation arm or the intervention arm. Subjects in the observation arm will start with an observational period of 13 months and then transition to the intervention arm for the remainder of their participation in the study.
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility 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-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.

Primary outcomes:
measure: Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events
timeFrame: Up to 3 years
measure: 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
timeFrame: Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months
Secondary outcomes:
measure: Safety of Reveal LINQ™ system and procedure - Percentage of subjects experiencing system or procedure related serious adverse events
timeFrame: Up to 6 months post Reveal LINQ™ device insertion attempt
measure: 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
timeFrame: Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Cardiovascular Associates of Mesa
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Mission Viejo
country: United States
facility: Saint Joseph Heritage Healthcare
state: California
city: Oxnard
country: United States
facility: Cardiology Associates Medical Group
state: California
city: Stockton
country: United States
facility: Saint Joseph's Medical Center
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates
state: Colorado
city: Boca Raton
country: United States
facility: FWD Clinical Research LLC
state: Florida
city: Brandon
country: United States
facility: Bay Area Cardiology Associates PA
state: Florida
city: Fort Pierce
country: United States
facility: Florida Heart Center
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute PA
state: Florida
city: Leesburg
country: United States
facility: Citrus Cardiology Consultants PA
state: Florida
city: Pensacola
country: United States
facility: Baptist Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Health
state: Indiana
city: Indianapolis
country: United States
facility: Ascension Medical Group - Saint Vincent
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Edgewood
country: United States
facility: Saint Elizabeth Healthcare
state: Kentucky
city: Louisville
country: United States
facility: Baptist Healthcare System
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Robbinsdale
country: United States
facility: North Memorial Health Heart &amp; Vascular Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Omaha
country: United States
facility: CHI Health Creighton University Medical Center - Bergan Mercy
state: Nebraska
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute PA
state: New Mexico
city: New York
country: United States
facility: Columbia University Irving Medical Center/NYPH
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Heart Center
state: New York
city: Roslyn
country: United States
facility: Saint Francis Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Greensboro
country: United States
facility: Cone Health
state: North Carolina
city: Wilmington
country: United States
facility: Novant Health New Hanover Regional Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel East
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research and Innovation Institute (OHRI)
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Health Cardiology a division of Doylestown Health Physicians
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Prisma Health Midlands
state: South Carolina
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Methodist Physicians
state: Tennessee
city: Fort Worth
country: United States
facility: Medical City Fort Worth
state: Texas
city: Tyler
country: United States
facility: Tyler Cardiovascular Consultants
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center Cherry Hill
state: Washington
city: Tacoma
country: United States
facility: Saint Joseph Medical Center (Tacoma WA)
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center (CAMC) Memorial Hospital
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Baylor Scott and White Health
name: Javed Butler, MD
role: PRINCIPAL_INVESTIGATOR
References: