Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
- Conditions
- Heart Failure NYHA Class IIIHeart Failure NYHA Class II
- 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
- COMPLETED
- 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
- 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
Scroll for more (43 remaining)Saint Joseph's Medical Center🇺🇸Stockton, California, United States