Heart Failure, Congestive Clinical Trial
Official title:
Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure
The SENSE-HF study is a prospective, observational, international multi-center study prospectively evaluating the sensitivity and positive predictive value of the OptiVol Fluid Trends data in predicting Heart Failure related hospitalizations and health care utilizations associated with signs and/or symptoms of pulmonary congestion, and to define OptiVol clinical guidelines for subject therapy management.
The SENSE-HF study prospectively evaluates the OptiVol feature in the prediction of Heart
Failure related events associated with signs and symptoms of pulmonary congestion and in the
subject HF therapy management.
The OptiVol feature is based on the measurement of daily intrathoracic impedance values,
measurements that can be used to track changes in the subject's thoracic fluid status over
time. An Alert warns the patient whenever a programmable threshold has been reached.
The study is divided into three phases.
The first phase is double-blinded and designed to determine the sensitivity and positive
predictive value of the OptiVol Fluid Trends data for the detection of Heart Failure related
hospitalizations with signs and/or symptoms of pulmonary congestion.
In the second phase of the study, the Alert is turned ON and the positive predictive value of
the first OptiVol Patient Alert for the development of signs and/or symptoms of pulmonary
congestion will be evaluated.
The third phase of the study allows for remote subject therapy management using the OptiVol
Patient Alert. The patient management strategy is then based on the experience gained in the
second study phase Physician actions taken in the occurrence of a Patient Alert will be
summarized.
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