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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
826
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.
Risk status guided medication intervention.
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
Saint Joseph's Medical Center
Stockton, California, United States
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.
Time frame: Up to 3 years
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.
Time frame: Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months
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.
Time frame: Up to 6 months post Reveal LINQ™ device insertion attempt
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.
Time frame: Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months
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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
Ft. Pierce, Florida, United States
Baptist Health
Jacksonville, Florida, United States
...and 43 more locations