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 LINQâ„¢ system and procedure in the study population.
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Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events
Timeframe: 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
Timeframe: Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months