Medication Management | Greensboro - Cardiology
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The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
Full description
The primary objective of this study is to collect physiological measurement data and heart failure (HF) event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor (ICM) systems. This study will not have pre-defined statistical endpoints. To support the primary objective, diagnostic sensor data will be compared to reference clinical testing data and heart failure decompensation events.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Patient is currently in NYHA Class II or III.
For patients with LVEF >40% measured on most recent available echocardiography within the previous 12 months:
For patients with LVEF <40% (for MI patients, measured no less than 30 days post-MI) on most recent available echocardiography within the previous 12 months:
Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app.
Patient is of legal age to give informed consent and is willing to participate in the trial.
Key Exclusion Criteria:
Primary purpose
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Interventional model
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525 participants in 1 patient group
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Central trial contact
Ming Duanmu; Alysia Rosner
Data sourced from clinicaltrials.gov
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