Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:Any
Start Date:February 2015
End Date:December 2016
Contact:Sanjeev Bhavnani, MD

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Pilot Study of Wireless Observed Therapy With an Ingestible Micro-Sensor Among Patients With Heart Failure and Left Ventricular Assist Devices

The investigators aim to develop a novel and wireless method for monitoring medication
adherence among heart failure patients with left ventricular assist devices (LVADs). Proteus
Digital™ has developed an ingestible and bio-absorbable micro-sensor as a strategy to
monitor medication compliance. The edible sensor has at its core a silicon-based integrated
circuit measuring 1.0 mm x 0.45 mm and is imbedded on a pill. Once ingested, this circuit is
activated by gastric acid resulting in an electrochemical redox reaction and an electrical
charge that is transmitted to a patch worn over the abdomen and wirelessly to a portable
device such as a smart phone. This strategy of medication adherence differs from
conventional adherence monitoring including pill counting and patient-recall by precisely
tracking medication ingestion.

The objectives are to assess the efficacy and safety of the Proteus Digital™ micro-sensor in
an exploratory investigation among heart failure patients with LVADs. Medication adherence,
specifically to anticoagulation is critically important in the post-implant period to
maintain LVAD function and to decrease thromboembolic complications; however, commonly
results in significant bleeding resulting in significant morbidity and mortality. In
addition, the anticipated degree of anticoagulation is unpredictable after LVAD implantation
due to factors related to changes in hepatic blood flow and endothelial dysfunction.
Enrolling 10 patients will provide results into the function of micro-sensor and to provide
a preliminary assessment of sensor-based activity, signal strength and signal duration in
LVAD recipients. Participants will be enrolled during an in-patient hospitalization to
assess the efficacy and safety of the device in a monitored setting.

Inclusion Criteria:

- Patients undergoing LVAD implantation for end-stage heart failure or admitted from the
out-patient setting

Exclusion Criteria:

- Unable to consistently consume oral intake

- Hemodynamic instability defined as hypotension requiring intravenous vasoactive
medications or arrhythmias requiring intravenous antiarrhythmics or oral
antiarrhythmics for rhythm stabilization

- Gastrointestinal bleeding requiring intravenous gastric acid secretion inhibitors
We found this trial at
San Diego, California 92121
San Diego, CA
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