Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
- Conditions
- Heart Failure NYHA Class IIIHeart Failure NYHA Class II
- Interventions
- Device: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware downloadOther: Medication intervention
- Registration Number
- NCT04452149
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 900
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm Medication intervention 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. Observation Arm Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download 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. Intervention Arm Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download 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.
- Primary Outcome Measures
Name Time Method Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events Up to 3 years The proportion of medication interventions with one or more associated medication intervention related SAEs will be evaluated.
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 Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status.
- Secondary Outcome Measures
Name Time Method 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 Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status.
Safety of Reveal LINQ™ system and procedure - Percentage of subjects experiencing system or procedure related serious adverse events Up to 6 months post Reveal LINQ™ device insertion attempt Freedom from Reveal LINQ™ system and procedure related serious adverse events at 6 months will be evaluated.
Trial Locations
- Locations (53)
Saint Joseph's Medical Center
🇺🇸Stockton, California, United States
Cardiovascular Associates of Mesa
🇺🇸Mesa, Arizona, United States
Arrhythmia Research Group
🇺🇸Jonesboro, Arkansas, United States
Saint Joseph Heritage Healthcare
🇺🇸Mission Viejo, California, United States
Cardiology Associates Medical Group
🇺🇸Oxnard, California, United States
South Denver Cardiology Associates
🇺🇸Littleton, Colorado, United States
FWD Clinical Research LLC
🇺🇸Boca Raton, Florida, United States
Bay Area Cardiology Associates PA
🇺🇸Brandon, Florida, United States
Florida Heart Center
🇺🇸Fort Pierce, Florida, United States
Baptist Health
🇺🇸Jacksonville, Florida, United States
First Coast Cardiovascular Institute PA
🇺🇸Jacksonville, Florida, United States
Citrus Cardiology Consultants PA
🇺🇸Leesburg, Florida, United States
Baptist Hospital
🇺🇸Pensacola, Florida, United States
Northside Hospital
🇺🇸Saint Petersburg, Florida, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Parkview Health
🇺🇸Fort Wayne, Indiana, United States
Ascension Medical Group - Saint Vincent
🇺🇸Indianapolis, Indiana, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Saint Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
Baptist Healthcare System
🇺🇸Louisville, Kentucky, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States
North Memorial Health Heart & Vascular Center
🇺🇸Robbinsdale, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Cardiology Associates of North Mississippi
🇺🇸Tupelo, Mississippi, United States
CHI Health Creighton University Medical Center - Bergan Mercy
🇺🇸Omaha, Nebraska, United States
Lourdes Cardiology Services
🇺🇸Voorhees, New Jersey, United States
New Mexico Heart Institute PA
🇺🇸Albuquerque, New Mexico, United States
Columbia University Irving Medical Center/NYPH
🇺🇸New York, New York, United States
Hudson Valley Heart Center
🇺🇸Poughkeepsie, New York, United States
Saint Francis Hospital
🇺🇸Roslyn, New York, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Cone Health
🇺🇸Greensboro, North Carolina, United States
Novant Health New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
The Lindner Research Center
🇺🇸Cincinnati, Ohio, 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
Cardiology Consultants of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Prisma Health Midlands
🇺🇸Columbia, South Carolina, United States
The Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
University of Tennessee Methodist Physicians
🇺🇸Memphis, Tennessee, United States
Medical City Fort Worth
🇺🇸Fort Worth, Texas, United States
Tyler Cardiovascular Consultants
🇺🇸Tyler, Texas, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Swedish Medical Center Cherry Hill
🇺🇸Seattle, Washington, United States
Saint Joseph Medical Center (Tacoma WA)
🇺🇸Tacoma, Washington, United States
Charleston Area Medical Center (CAMC) Memorial Hospital
🇺🇸Charleston, West Virginia, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States