Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Failure NYHA Class II
- Heart Failure NYHA Class III
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Following LINQ™ device insertion, subjects will be randomly allocated in a 2:1 ratio to either the observation arm or the intervention arm. Subjects in the observation arm will start with an observational period of 7 months and then transition to the intervention arm for the remainder of their participation in the study.Masking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 300 subjects at up to 30 sites in the US, and will characterize the safety of the patient management pathway. Subjects will be followe...
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 300 subjects at up to 30 sites in the US, and will characterize the safety of the patient management pathway. Subjects will be followed for a minimum of 7 months, and until study closure.
Tracking Information
- NCT #
- NCT04452149
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Javed Butler, MD University of Mississippi Medical Center
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